As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Friendly’s Manufacturing and Retail LLC — Wilbraham, MA
The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to the president and CEO, Eric Beringause.
During an inspection at Friendly’s Manufacturing and Retail LLC, ready-to-eat (RTE) food manufacturing facility, July 29 to Aug. 20 this year, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation in the Federal Code. The facility manufactures RTE food products including ice cream products such as scrounds, sundae cups and decorated cakes, as well as various syrups, and fudge.
“During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes, a human pathogen, in your facility, which matches the same strain found during FDA’s 2017 inspection,” according to the warning letter.
“FDA’s inspection resulted in the issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the RTE food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.”
In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.
The FDA says they received a written response dated Aug. 15, 2019, describing corrective actions taken and planned by the firm.
The violations noted by the FDA:
- “Your hazard analysis did not identify a known or reasonably foreseeable hazard that requires a preventive control, as required by 21 CFR part 117.130(a)(1). Specifically, you did not appropriately evaluate environmental pathogens as required by 21 CFR part 117.130(c)(ii). You manufacture RTE food products that are exposed to the environment at several steps where the food could be contaminated with environmental pathogens, such as L. monocytogenes, and the food does not receive a subsequent control for environmental pathogens. Your “FSMA/FOOD SAFETY PLAN” issued on June 10, 2019, lists pre-requisite programs (PP) and Sanitation Standard Operating Procedures (SSOP), “PP1- Environmental Monitoring,” “PP3-current Good Manufacturing Practices,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “PP7-SSOPs,” at processing steps where food is exposed to the environment, as reasons that a hazard (e.g., L. monocytogenes) does not require a preventive control. However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These measures should not be considered when determining whether sanitation preventive controls are needed. Environmental monitoring (e.g., Dean Foods’s corporate environmental monitoring program “PP1- Environmental Monitoring Preventive Control” and/or your facility specific “Pathogen Environmental Monitoring Program”) is needed to verify that environmental pathogens are being controlled by the sanitation control measures.”
“One environmental swab collected from the floor area of (redacted) during FDA’s 2019 inspection contained L. monocytogenes. (According to your Plant Manager, food products manufactured during our environmental swabbing were discarded.),” according to the warning letter.
“In addition, L. monocytogenes was found in seven environmental swabs collected during FDA’s 2017 inspection, including one that was also from the floor in (redacted). Further, your firm’s environmental testing results from May 1, 2018, to July 5, 2019, for swabs collected from the WC4 area show several Listeria spp. positive swabs. Whole genome sequencing (WGS) of positive isolates detected in FDA’s environmental swabbing determined that the eight positive swabs collected during our 2017 and 2019 inspections contain the same strain of L. monocytogenes. We advised you of those WGS results via a conference call on August 16, 2019. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in your facility since 2017.
“These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”
“Additionally, during FDA’s 2019 inspection, two environmental swabs were positive for Listeria innocua (L. innocua). One of the L. innocua swabs was collected from ice cream dripping from a valve on a freezer cycle in (redacted) where Friendly’s brand strawberry shortcake sundaes were being manufactured. This location is adjacent to a drain where, in 2017, FDA isolated L. monocytogenes and L. innocua. The second L. innocua swab was collected from a floor drain in the (redacted) area. This swab site was in the same location as a previous L. monocytogenes positive sample collected by FDA during our 2017 inspection. Additionally, your firm’s environmental testing results for swabs collected in the (redacted) area showed multiple Listeria spp. positive swabs between January 10, 2018 to July 24, 2019.”
“In reviewing your firm’s environmental monitoring program, we note that you have repeatedly found Listeria spp. throughout your processing facility. Specifically, from January 2019 through July 2019, 13.4% of all swabs taken were positive for Listeria spp.; from January 2018 through December 2018, 20.9% of all swabs taken were positive for Listeria spp.; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for Listeria spp. Your 2017 environmental monitoring findings were discussed with your firm during our 2018 Regulatory Meeting.”
“You committed to performing corrective actions in written responses dated August 15, 2019, and September 11, 2019. Your September 11, 2019, corrective action response indicates that your food safety plan’s hazard analysis was updated to identify environmental pathogens as a hazard requiring preventive controls and identified sanitation controls (Sanitation Standard Operating Procedures and Sanitation Preventive Controls-PC2 and Good Manufacturing Practices- PC7) to address the hazard. In your written responses, you indicate that you have taken a number of corrective actions, which include performing an intensified cleaning and sanitizing of your production area; conducting a root cause analysis in response to our environmental findings; shutting down (redacted) to perform targeted remediation work, clean and sanitize, and conduct verification swabbing; conducting a refresher training for employees; and performing intensified cleaning of all utensils, work surfaces, and equipment. We recommend that you continue to implement these corrective actions to ensure that L. monocytogenes does not contaminate your RTE food products. We will verify the implementation and adequacy of these corrective actions during our next inspection.”
- “You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). As evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).”
“As noted above, your September 11, 2019, corrective action response identified sanitation controls (Sanitation Standard Operating Procedures and Sanitation Preventive Controls-PC2 and Good Manufacturing Practices- PC7) to address the hazard of environmental pathogens such as L. monocytogenes. The corrective actions include intensified daily cleaning throughout the plant, shortened production schedules and coordinated cleaning programs among the Work Centers, which could allow for more cleaning time and reduce foot traffic and water splash issues; testing each production line during production to determine negative results; and the hiring of additional Quality Assurance technicians and sanitarians to improve the environmental monitoring plant-wide. We will verify the implementation and adequacy of these corrective actions during our next inspection.”
Current Good Manufacturing Practice (Subpart B):
- “You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Specifically, your sanitation control procedure, “PP3 Current Good Manufacturing Practices,” (redacted) products or product contact surfaces. Gloves must be maintained intact, clean and in sanitary condition.” However, the following practices were observed:”
- “An employee in charge of mixing (redacted) did not wash and sanitize his hands and did not wash, sanitize, or change his gloves after touching scoop handles that contained (redacted), opening boxes of (redacted), and transferring (redacted) to the decorating lines.”
- “Your corporate Quality Assurance Director was observed using his bare hands to push partially overturned RTE sundae cups through the (b)(4) machine. Afterward your corporate Quality Assurance Director was observed licking ice cream off his bare hands.”
“These types of practices are a repeat observation from our 2017 inspection. Your firm’s corrective action response received on September 11, 2019, addresses the immediate concerns as well as outlines long term corrective actions that you plan on implementing, including re-training your employees on the usage of gloves and updating your RTE Brill handling process to address this observation. We will verify the adequacy of these corrective actions during our next inspection.”
- “Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4). Specifically, (redacted) on (redacted) were observed with continuously dripping condensate from overhead pipes collected over the single filler heads while filling containers with RTE ice cream. Condensate was also observed dripping continuously from overhead manifold pipes on (redacted) onto floors below where it pooled, and these areas were observed with high foot traffic and pallet traffic. Condensate continuously dripped from overhead pipes and collected on a plexiglass shield placed above the assembly line on (redacted). Condensate was observed to occasionally drip from one corner of the shield onto to the assembly line and onto the outerwear of employees decorating RTE cakes and onto the RTE topping hopper.”
“Condensate deficiencies are a repeat observation from our 2017 inspection. Your firm’s corrective action responses received on August 15, 2019 and September 11, 2019, address the immediate sanitation concerns as well as outline long term corrective actions that you plan on implementing, including consulting with a third-party expert to assist in assessing how to implement better condensate control within your environment and implementing corrective action measures based on your findings. We will verify the adequacy of these corrective actions during our next inspection.”
- “You did not clean your utensils and food contact surfaces of equipment as frequently as necessary to protect against contamination of food, as required by 21 CFR § 117.35(d). Specifically:”
- “Your sanitation control procedure, “SSOP1 Cleanliness of Food Contact Surfaces,” states that “all food contact surfaces shall be cleaned and sanitized daily or as used.” However, the following practices were observed:”
- “Cake molds had food debris (white and chocolate ice cream) from previous use when exiting the dishwasher. Employees continued to use these molds without sending the molds back through the dishwasher.”
- “An employee used a metal ruler to push RTE products into a topping hopper and then placed the ruler on an unclean work cart. This ruler was used throughout production operations and was not observed being cleaned and sanitized.”
“Your firm’s corrective action responses include actions your firm will take to address these findings which include updating your Sanitation Preventive Controls -PC2 to require that molds and RTE surfaces in cake production be (redacted) at (redacted); and implementing policies that only devices constructed from (b)(4) material that have been cleaned and sanitized may be used to push RTE product down hoppers and for other food contact activity. We will verify the adequacy of these corrective actions during our next inspection.”
- “You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically:”
- “Your SOP “PP3 Current Good Manufacturing Practices” states that “cleaning and sanitizing of utensils and equipment should be carried out in a manner that prevents contamination of raw material, food packaging supplies, and finished product.” However, we observed the use of unrestrained high-pressure hose during cleaning and sanitizing of floors and equipment leading to overspray in active lines producing RTE ice cream products, which had the potential for contamination of these products. Specifically,”
- “Overspray was observed during equipment and floor cleaning activities on (redacted) adjacent to production activities on (redacted) where an employee was observed routinely opening the lids of the (redacted) mixing vats to monitor mixing of pasteurized chocolate mix.”
- “Overspray was observed during equipment and floor cleaning activities on (redacted) adjacent to production activities on (redacted) filler line and fruit feeder line with a plastic curtain divider in between. This high-pressure hose usage resulted in overspray from unclean equipment to aerosolize, causing the mist to rise above the curtains towards the fruit feeder where a production employee was routinely opening the fruit feeder hopper to add pecans on the (redacted) line.”
iii. “Employees were observed using high pressure hoses during the (redacted) cleaning activities on (redacted), which caused overspray onto the (redacted) cloths covering RTE (redacted) vanilla icing.”
- “Employees were frequently observed handling hoses to wash down spills and excess food debris from the floors on (redacted) during ongoing production activities which resulted in overspray from the floors onto RTE chocolate fudge fillers and RTE fruit feeders containing nuts.”
“Your firm’s corrective action responses outline corrective actions to address the immediate sanitation concerns observed during the current inspection, including restricting the use of high-pressure hoses near in-use production lines. Additionally, in the longer-term, you will replace these high-pressure hoses with ones that are high flow/low pressure, and you will re-train your employees on how to properly use this piece of equipment. We note that the use of spray hoses next to in-process product was documented by our investigator during FDA 2017 inspection Your response to FDA’s 2017 inspection findings also stated that you would re-train your employees. As evidenced from our current inspection, your past corrective actions do not appear to have long lasting or effective results. We strongly encourage you to reassess and implement programs that are effective.”
- “Our investigators observed the following practices involving pails and brushes which do not protect against contamination of food, food-contact surfaces, and food-packaging materials”
- “Green pails designated for finished products/ingredients were used to hold overflow ice cream during production and were placed directly below pipes from which condensate dripped into them. These pails were also observed being emptied into a discarded product vat during which the rim and exterior of the pails came into contact with the discarded food and the food vat and then returned to the production line without any cleaning or sanitizing.”
- “Employees were observed moving orange pails to multiple surfaces within the production environment without cleaning or sanitizing the pails between uses. These surfaces include, floors, RTE product work counters, and the assembly conveyor. In addition, employees were observed using yellow brushes designated for “exterior surfaces,” such as wheels and floors, to scrub areas around food contact surfaces such as conveyor belts, scales, work tables.”
“Your firm’s corrective action responses include actions your firm will take to address these findings, which include outlining specific uses for your green and orange pails and having a schedule to clean and sanitize your pails which will be monitored in your daily production records. We will verify the adequacy of these corrective actions during our next inspection.”
- “You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically,”
- “(redacted) cloths were observed being used and re-used without adequate cleaning and sanitizing of the cloths. We observed (redacted) cloths being used in various activities during production, including wiping down condensate, conveyors, scales, and RTE cake decorating stands; covering food; and wiping off excess food from the sides of cake molds. For example, we observed an employee using (redacted) cloths to wipe condensate on pipes and then using the same cloth to touch cakes while decorating.”
- “Disassembled parts and pipes from the (redacted) filler were stored inside the handwashing sink in (redacted). During (redacted) sanitation, (redacted) guards disassembled from the (redacted) filler were stored on wet production floors next to a floor drain with high foot traffic at the (redacted) line.”
- “Hoses used for sanitizer and water were not clearly marked and were observed being placed directly on wet floors, over flavor vats, and on top of multiple product contact work surfaces.”
“Your firm’s corrective action responses include actions your firm will take to address these findings which include using (redacted) towels only throughout the plant for equipment, pipes, and other non-food contact surfaces; updating your written programs, SSOP 1 Cleanliness of Food Contact Surfaces and Current GMPs-PC-7; and identifying your sanitation hose (redacted). We will verify the adequacy of these corrective actions during our next inspection.”
A complete list of the violations can be found in the FDA’s warning letter.
Hill’s Pet Nutrition Inc. — Topeka, KS
The Food and Drug Administration sent a warning letter dated Nov. 20, to the president and CEO of Hill’s Pet Nutrition, Peter Brons-Poulsen.
During an inspection at Hill’s Pet Nutrion’s manufacturing facility on Feb. 1-19 and Mar. 25-27, this year, FDA investigators confirmed that animal food products with unsafe levels of vitamin D were manufactured and marketed by your firm. The warning letter says that, “the unsafe amounts of vitamin D cause your products listed below to be adulterated because they bear or contain a food additive that is unsafe within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.
The FDA says they received a written response dated Mar. 12, 2019, May 23, 2019, and Aug. 30, 2019, describing corrective actions taken and planned by the firm. The FDA also acknowledges that the firm initiated several voluntary recalls for excessive amounts of vitamin D in various finished products.
The violations noted by the FDA:
Adulterated Animal Food – Unapproved Food Additive
“On February 11 and 12, 2019, during a complaint investigation, FDA collected for vitamin D analysis two samples of your Hills Prescription Diet Digestive Care i/d Low Fat (SKU Number 10423) canned dog food. These samples were part of the lots covered by your recall. Testing of the products revealed the following results:”
- “Lot code BEST BEFORE 10 2020, T1911124 3912, found 100,170 to 107,282 IU/kg of vitamin D in your canned dog food.”
- “Lot code BEST BEFORE 10 2020, T1911125 3912, found 102,829 to 102,346 IU/kg of vitamin D in your canned dog food.”
“A food additive is a substance that becomes a component of food unless it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.5 According to scientific literature reviewed and summarized by scientific committees in the National Research Council, and the 2017 Official Publication of the Association of American Feed Control Officials on pages 149-162, vitamin D in dog food is safe in the amount of 500 to 3,000 IU/kg.7 According to the scientific literature, concentrations of vitamin D in dog food above 4,000 IU/kg dry matter cause signs of vitamin D toxicosis, with severity of signs increasing with increasing concentrations of the vitamin.7 Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.”
“The above-referenced dog food samples contained vitamin D at levels in excess of 33 times the recommended safe upper limit. At these levels, vitamin D is not generally recognized as safe; therefore, it is a food additive. Under section 409 of the Act (21 U.S.C. § 348), a food additive is unsafe unless a regulation is in effect that prescribes the conditions under which the additive may be safely used, and the additive and its use or intended use are in conformity with that regulation. We are not aware of any regulation that would allow the use of vitamin D at the levels found in the above-referenced canned dog food. Therefore, the vitamin D is an unsafe food additive and the canned dog food containing these elevated levels of vitamin D is adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)].”
Adulterated Animal Food – Hazard Analysis and Risk-Based Preventive Controls Requirements
“During our inspection of your facility, FDA Investigators noted violations of the Hazard Analysis and Risk- Based Preventive Controls requirements for animal food found in Title 21 of the Code of Federal Regulations, part 507, subpart C (21 CFR part 507, subpart C). These violations render your animal food products adulterated under the FD&C Act.9 Violations observed during the inspection include, but are not limited to, the following:”
“Your firm did not sufficiently assess the probability that a vitamin D toxicity or deficiency hazard will occur in the absence of a preventive control as required by 21 CFR 507.33(c)(1).”
“Specifically, your firm uses vitamin premix in the manufacture of animal food products, but your firm failed to implement your prerequisite program to ensure that the vitamin premix did not contain an excess of vitamin D, which is a known or reasonably foreseeable hazard that could occur in the absence of a preventive control. As stated in your food safety plan’s risk assessment matrix for your vitamin premix, you were relying on a (redacted) to prevent nutrient deficiencies and toxicity hazards (redacted), which you classified as a high risk chemical hazard. You noted that “[i]f the raw materials or other ingredients do not contain nutrients at the expected levels, this may result in either a nutrient deficiency or toxicity hazard when the ingredient is incorporated into the animal food based on a preset formulation.” Your food safety plan also stated that “[c]hemical hazards identified as high risk require the hazard be analyzed and be within acceptable limits prior to unloading the specific raw material into the manufacturing facility.””
“However, the vitamin premix was not analyzed and subsequently reviewed to ensure that the vitamin D added to final products from the premix would meet your firm’s pre-set formulation. Your ingredient specification for the vitamin premix included a target specification for vitamin D and states that the “Supplier must include Certificate of Analysis (redacted),” but your firm did not obtain Certificates of Analysis (COA) upon receipt (redacted) of vitamin premix from your supplier. Your firm also failed to test, evaluate against your specification, and subsequently reject the vitamin premix containing excess vitamin D, as required by your food safety plan. As a result, you used vitamin premix containing a concentration of vitamin D that was outside your specification.”
“As a result of your failure to follow your food safety plan, the hazard of vitamin D toxicity was not adequately managed at your receiving step. Therefore, you did not reduce the probability that the hazard would occur in the absence of a preventive control. As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food as identified above. The systematic failure also resulted in adulterated animal food, as described above.”
“We acknowledge your promised corrective actions in your written responses dated March 12, 2019, May 23, 2019, and August 30, 2019 to the Form FDA 483, which include implementing a (redacted) Certificate of Analysis (COA) requirement for vitamin premixes and trace mineral premixes, revising the Receiving Procedure to address the need for (redacted) COAs (redacted), training personnel on the revised Receiving Procedure, integrating COA requirements into an internal system so that incoming vitamin and trace mineral premix ingredients cannot be received without conforming COAs, conducting an onsite audit of your supplier’s facility, revising your Food Safety Plan, and implementing a process preventive control for the (redacted) steps to enhance control of the misformulation hazard.”
“We are unable to assess the adequacy of your corrective actions because many are preexisting procedures that were not followed consistently prior to the recall event. For example, your requirement for vitamin premixes with vitamin D to have a COA (redacted) was documented in your ingredient specification before the recall. This was further confirmed by your firm’s special instructions to your supplier (redacted). In your response to the Form FDA 483, you stated that your food safety plan was not intended to cover “misformulation” by your supplier. (redacted) and noted that “[n]utrient deficiency or toxicity hazards can be the result of incorrect levels of nutrients in incoming raw materials or ingredients.””
“Your response states that your firm is now implementing a process preventive control at the (redacted) step; however, you did not provide adequate documentation demonstrating the implementation and effectiveness of the preventive control to include the associated management components as required by 21 CFR 507.39 and therefore we are unable to determine the adequacy of this corrective action.”
“The corrective action of a “process preventive control” at your (redacted) step (redacted). However, it does not address the root cause of this incident, which was accepting an ingredient without confirming that it contained vitamin levels that were within specification as required by your procedures.”
“FDA will verify your proposed voluntary corrective actions during a future inspection of your firm.”
A complete list of the violations can be found in the FDA’s warning letter.
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