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.
Yost Foods, LLC. — Brunswick, OH
The Food and Drug Administration sent a warning letter dated Sept. 10, 2019, to the President of Yost Foods LLC, William Yost.
During an inspection at Yost Foods LLC Ready-to-Eat (RTE) spice manufacturing facility on March 18 through April 24, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
FDA investigators collected environmental samples from various areas in the processing facility. They also found the presence of Listeria monocytogenes. They also gathered documentation that one of the company’s customers tested and found Yost Foods LLC aji amarillo paste to be positive for L. monocytogenes. The company voluntarily recalled and destroyed the product.
The FDA received a response dated Aug. 8, 2019, to the FDA 483a FSVP observations form issued on June 28, 2019.
In response to these deviations, the FDA issued an FDA 483, Inspectional Observations report that lists deviations observed at the facility.
The violations noted by the FDA:
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
- “You did not 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). Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), Yost Foods, Inc, Food Basics.” Your SSOP specifies that (redacted). Our investigator observed that the QA review occurred after cleaning but prior to the (redacted) step. Further, your SSOP states (redacted). However, your records dated February 22, 2019, April 1, 2019, and April 3, 2019, only document rinsing of the equipment during corrective actions.”
“In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (redacted). (redacted) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (redacted). Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).”
“We have reviewed your May 14, 2019 response indicating that your firm is implementing a number of corrective actions, including updating your cleaning procedures, updating your Sanitation Pre-Operational Checklist, hiring a sanitation consultant to re-train associates on proper cleaning technique, reassessing your food safety plan, conducting additional sanitation activities, and testing environmental swabs for L. monocytogenes. We will verify the adequacy of your corrective actions during a future inspection.”
- “You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (redacted). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (redacted). Your weekly environmental monitoring program for Listeria spp. (redacted). Each time, your corrective actions were limited to (redacted). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices.”
“We have reviewed your May 14, 2019 response indicating that your firm has updated your Environmental Pathogen Monitoring Program to include corrective action and investigation procedures. We will verify the adequacy of your corrective actions during a future inspection.”
Current Good Manufacturing Practice (Subpart B):
- “You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (redacted) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (redacted), (redacted) hopper, and (redacted) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe.”
“We have reviewed your May 14, 2019 response indicating that your firm has updated your cleaning procedures and hired a sanitation consultant to re-train associates on proper cleaning technique. We will verify the adequacy of your corrective actions during a future inspection.”
A complete list of the violations can be found in the FDA’s warning letter.
Cerreta Candy Company Inc. — Glendale, AZ
The Food and Drug Administration sent a warning letter dated Aug. 19-26, 2019, to the Vice President of Cerreta Candy Company, Inc., Jonathan Cerreta.
During an inspection at Cerreta Candy Company Inc.’s manufacturing facility FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.
In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA:
Hazard Analysis and Risk-Based Preventive Controls (Subparts C and G):
- “Your hazard analysis did not identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.”
- “The hazard analysis for “[Chocolate] Molding,” which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.”
- “The hazard analysis for “[Chocolate] Molding,” which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.”
- “The hazard analysis for (redacted), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.”
“Although you stated in your response that you have revised your hazard analysis for each of the production processes and evaluated each ingredient and process step to ensure any hazards are being controlled, you did not provide this documentation in your response, so we are unable to evaluate the adequacy of these corrections.”
- “You did not establish and implement adequate written procedures for environmental monitoring, as required by 21 CFR 117.165(b). You manufacture RTE foods such as candies, chocolates, candy-coated popcorn, nuts, taffy and snack foods, which are manipulated by employees and exposed to the environment at numerous stages of manufacturing and do not receive a subsequent control to significantly minimize or prevent environmental pathogens. For example, your peppermint snow mints are exposed to the environment after entering the (redacted) tank, during the molding process, including employee placement of molds onto a conveyer belt as well as (redacted) addition of ingredients into a (redacted), through a (redacted), when employees remove product from molds (at the “popping” station) and when bulk packaged into boxes. Further, you use (redacted) peanuts as an ingredient which could be a source of environmental pathogens such as Salmonella. You have identified a “Cleaning and Sanitation Program” (i.e., sanitation controls) as a preventive control to significantly minimize or prevent the hazard of environmental pathogens (identified in your hazard analyses for molding, (redacted), and roasting). Your environmental monitoring procedure (2.4.8) specifies “6 Salmonella swab tests on equipment and/or stations that come into contact with finished or RTE products on an (redacted) basis”; however, the number and location of sampling sites as well as frequency of sampling are not adequate to determine whether your sanitation preventive controls are effective. You (redacted) of equipment in the kitchen, retail, and chocolate production areas. Of these swabs, you (redacted) swab related to your peppermint snow mints production at the popping station. Further, performing environmental monitoring (redacted) is not sufficient to determine whether your controls are effective. In addition, you should evaluate whether Listeria monocytogenes is an environmental hazard for your RTE foods that are exposed to the environment and whether you should also conduct environmental monitoring for Listeria spp. to verify sanitation controls.”
“In your written response you committed to revising your environmental monitoring program and indicated you would conduct a study of (redacted) in your facility to evaluate the potential risk of environmental pathogens such as Salmonella, E. coli, and Listeria. We are unable to evaluate the adequacy of your intended corrective action as you did not include the study of your facility or a revised environmental monitoring program.”
- “You did not 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 you facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). You receive (redacted) peanuts from your supplier that are used in your RTE nut butters and milk chocolate peanut clusters. Your hazard analysis for “Roasting” identifies Salmonella as a food safety hazard requiring a preventive control and specifies that this hazard is controlled through your supplier assurance program in which a Certificate of Analysis (COA) is provided by the supplier. The documentation provided by the supplier identifies (redacted) and indicates that peanut products that have undergone their (redacted).” (redacted) and is not a kill step for Salmonella. Furthermore, the (redacted) peanuts are received with a label that states that ” it is recommended that (redacted) peanuts (redacted).” There is no indication that your supplier is controlling Salmonella in the (redacted) peanuts. Therefore, you cannot control the hazard through supplier controls. The (redacted) peanuts are roasted at your facility. Although roasting is generally a preventive control for Salmonella in (redacted) peanuts, you do not treat the roasting process as a control for Salmonella. To establish your roasting as a process preventive control, you would need to, among other things, validate that the process is adequate to significantly minimize the hazard (Salmonella) in accordance with 21 CFR 117.160.”
- “You did not implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard requiring a supply-chain-applied control as required by 21 CFR. 117.405(a)(1).”
- “You identified in your hazard analysis for “Roasting” a “Supplier Assurance Program” as the preventive control for pathogens in tree nuts such as almonds, pecan halves, cashews, filberts, and Brazil nuts, but you have not established supplier verification activities in accordance with 21 CFR part 117 subpart G for your suppliers of tree nuts.”
- “You identified in your hazard analysis for “[Chocolate] Molding” a “Supplier Assurance Program” as the preventive control for natural toxins and for pesticides in raisins; your hazard analysis states that the product is received from a “supplier who only receives product and services from partners that are required to act in accordance with all applicable federal, state, and local laws and regulations,” but you did not specify any supplier verification activities. This was also the case for pathogens, natural toxins, and pesticides in dried cranberries.”
“Although your written response stated you are obtaining documentation proving the hazards associated with the raw materials are being eliminated by your supplier; you did not provide these documents in your response, so we are unable to evaluate the adequacy of your corrective action.”
- “You did not document the monitoring of allergen preventive controls, as required by 21 CFR 117.145(c)(1).”
- “Your Product Tracking Sheet records from January to August 2019 show that you manufactured both peanut butter and almond butter on January 9, February 11, April 11, 2019, April 29, June 12, and July 2, 2019. Your procedure 2.8.1 Allergen Management for Food Manufacturing states in section 220.127.116.11 that (redacted), labels are gathered with ingredients and approved by a production manager” and ” [t]inished product is inspected by production manager (redacted).” However, you did not document on your Product Tracking Sheet or any other monitoring record maintained by your firm that labels were approved (redacted) and that finished products were inspected (redacted) in order to significantly minimize or prevent the hazard of undeclared allergens due to incorrect labeling.”
- “Your procedure 2.8.1 Allergen Management for Food Manufacturing, states in section 18.104.22.168 “[i]f a changeover between allergen[ s] becomes necessary, all equipment, utensils, and food contact surfaces are to be properly and effectively cleaned and sanitized.” Your firm manufactured both peanut butter and almond butter on January 9, February 11, April 11, April 29, June 12, and July 2, 2019; however, your (redacted) Cleaning and Sanitation Tracking records did not document that cleaning/sanitation of the (redacted) occurred between the production of peanut and almond butter on four of these six dates (February 11, April 11, June 12, and July 2, 2019), and you could not locate the (redacted) Cleaning and Sanitation Tracking record for April 29, 2019.”
“Although you stated in your response that you have updated the Product Tracking Sheets to include start times for production, packaging, and cleaning and sanitation processes, you did not provide these documents in your response, so we are unable to evaluate the adequacy of your changes.”
Current Good Manufacturing Practice (Subpart B):
“You did not take effective measures to exclude pests from your food plant and to protect against contamination of food by insects, as required by 21 CFR 117.35(c). Specifically, on August 19-20, 2019, the following conditions were observed:”
- “In the ambient storage room where boxes, packing materials, label rolls, and various other pieces of equipment are stored, apparent rodent excreta pellets (AREPs) were observed on the floor along the east wall and in front of the west wall, which appeared to be rodent damaged. A gap of approximately two inches was observed at the bottom of the double doors located on the south side of the ambient storage area. Because these double doors exit to the exterior of the building, the gap provides an entry for rodents and other pests.”
- “In the cold room where raw materials and finished products are stored, apparent rodent gnaw marks were observed on the corner of (redacted) boxes of jumbo runners/peanuts, on a piece of milk chocolate raspberry candy, and on the wrappers of a partially opened box of individually-wrapped one-ounce milk chocolate bars.”
- “AREPs were observed in the cold room on the floor behind and on the bottom of one pallet of jumbo runners/peanuts, on top of a pallet of cashews stored beside the peanuts, on the floor along the south wall where pallets with boxes of bulk finished product and in-process materials were stored, on the bottom shelf along the north wall toward the east side of the cold room where finished/packaged products are stored, on the bottom shelf in the middle of the north wall, and in the northeast corner where boxes of chocolate candies and packing materials are stored.”
- “A pallet containing apparent re-work material of peppermint snow mints in the cold room was observed to have AREPs inside the box and outside of the plastic bag containing the product.”
- “Apparent rodent gnaw marks were observed on a bag of un-popped corn kernels in the production area on the south side of the facility near the kitchen where popcorn, caramels, and various other products are manufactured. AREPs were observed underneath a table adjacent to where the kernels were stored.”
- “A gap of approximately two inches was observed at the bottom of the double doors located on the south wall of the receiving area. These double doors exit to the exterior of the building, and the receiving area opens directly into the production area.”
“During the inspection, you cleaned areas where AREPs were observed, repaired damaged areas of the walls and gaps found in the doors that exit the building, and voluntarily destroyed product with suspect rodent activity, including raw materials and finished product. Your written response further indicates you will be monitoring for rodent activity and are conducting (redacted) inspections for pest activity. Implementation of these corrective actions will be verified during the next inspection.”
“As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operations and the products that you distribute are in compliance with the law.”
A complete list of the violations can be found in the FDA’s warning letter.