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.
Country Fresh Inc. — Spring, TX
The Food and Drug Administration sent a warning letter dated Dec. 12, 2019, to the CEO of Country Fresh Inc., William Anderson.
During an inspection at Country Fresh inc. ready-to-eat (RTE) food manufacturing facility, on July 9 to 17, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117). The warning letter says that, “FDA collected environmental samples from various areas in your facility, including areas that are near food processing operations. FDA laboratory analyses of the environmental samples (i.e., swabs) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that your RTE products are 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 they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they 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 violations noted by the FDA:
- “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 of the Act 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).”
- “You did not identify and implement a preventive control adequate to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes from contaminating RTE produce in your facility, as required by 21 CFR 117.135(a)(1) and (c)(3). The failure to have an adequate preventive control that significantly minimizes or prevents the environmental hazard of L. monocytogenes is reflected in Seven (7) environmental swabs (sample # 1113254) collected by FDA during our most recent inspection at your Country Fresh location in Grand Prairie, TX that were positive for L. monocytogenes. These samples were collected from the rubber base of the cutting table located on the NE side, the floor drain located on the SE side of the feeding table, the right leg of the pallet jack in the cold storage area, the East side of the cracked floor between the Fruit Room (redacted) and cold storage, the middle of the cracked floor between the Fruit Room (redacted) and cold storage, the blue squeegee in Fruit Room (redacted), and the left back side of the orange cull waste basket in Fruit Room (redacted). Furthermore, a retail product sample of watermelon spears (sample # 1108315) collected at Wal-Mart on May 9, 2019, by FDA tested positive for L. monocytogenes. The watermelon spears were manufactured at your Country Fresh location in Grand Prairie, TX. WGS of the sample revealed that it matched an environmental sample collected by the State of Texas in 2013 at your Country Fresh location in Houston, TX and historical clinical isolates. You stated that the two Country Fresh locations (Grand Prairie and Houston) shared product, equipment, and suppliers.”
“These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes from contaminating RTE fresh cut produce 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.”
- “You did not implement your preventive control to prevent cross-contamination during washing. Your firm identified holding fruit in (redacted) for (redacted) to (redacted) as a critical limit to control for pathogens such as Listeria monocytogenes and Salmonella. In addition, you stated that employees are required to (redacted). On July 9, 2019, the FDA investigator observed an employee on the cantaloupe line not allowing the fruit (redacted) for (redacted) as required in your food safety plan. In addition, you do not have monitoring records to document employees are allowing fruit (redacted) for (redacted) to (redacted).”
- “You did not validate that your preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system, to comply with 21 CFR 117.160. Specifically, you did not properly validate your preventive control for the use of (redacted) to prevent cross-contamination. The study presented by your firm is titled “EPA Food Contact Sanitizer Test for Previously Cleaned Food Contact Surfaces (AOAC Germicidal and Detergent Sanitizing Action of Disinfectant) against Salmonella choleraesuis and Listeria monocytogenes.” That study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of peracetic acid against pathogen cross-contamination during the produce washing process.”
A complete list of the violations can be found in the FDA’s warning letter.
Tugusto Foods, Inc. — Bayamón, Puerto Rico
The Food and Drug Administration sent a warning letter dated Dec. 17, 2019, to the President and CEO of Tugusto Foods, Inc., Jaime Franco Salamanca.
During an inspection at Tugusto Foods, Inc.’s manufacturing facility on May 7-8, 2019, and June 7, 2019, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
The warning letter says that the FDA “determined that the food products manufactured in your facility are 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 they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).”
In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility.
The violations noted by the FDA:
- “You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility (including seasonings and spices), as required by 21 CFR § 117.126(a)(1). A food safety plan must include the following:”
(1) “The written hazard analysis, as required by § 117.130(a)(2);”
(2) “The written preventive controls, as required by § 117.135(b);”
(3) “The written supply-chain program, as required by subpart G;”
(4) “The written recall plan, as required by § 117.139(a);”
(5) “The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);”
(6) “The written corrective action procedures, as required by § 117.150(a)(1);”
(7) “The written verification procedures, as required by § 117.165(b).”
- “You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a).”
- “You did not identify pathogens as a known or reasonably foreseeable hazard to determine whether pathogens are a hazard requiring a preventive control. Your facility manufactures various seasoning and spice products (redacted) Pathogen contamination has been associated with ingredients in seasonings and spice products that have not undergone lethal treatment and are used in manufacturing.”
- “You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures various products (redacted) These ingredients have been associated with mycotoxins.”
- “You did not evaluate environmental pathogens, such as Salmonella, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.”
“Your response indicates that you hired a consulting firm, (redacted) to develop your Food Safety Plan (FSP) by the end of August 2019. However, it is not clear if (redacted) will be developing an FSP for your firm because it is not outlined in the Service Agreement that was sent to FDA. It appears that (redacted) will only be conducting a mock food safety audit at your firm concerning your firm’s compliance with 21 CFR Part 117, subpart B (CGMPs), and will provide your firm with a written or oral report describing observations. The audit will not document your firm’s compliance with the Preventive Controls requirements. Furthermore, the agreement does not specify if a written hazard analysis will be conducted for your firm, including developing written preventive control programs and procedures. The adequacy of your food safety plan, including your hazard analysis and related procedures, will be verified during the next inspection.”
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, as required by 21 CFR Part 117.35(c). Specifically, on May 7, 2019, and May 8, 2019, your firm manufactured “Sazón con Culantro y Achiote” (Seasoning with (redacted)) (redacted4)oz. and (redacted)lbs. and also repacked “Agrandador de Sabor” ((redacted)) (redacted)oz.”
- “At the entrance of the production and packing area, inside your facility, your firm had an (redacted) bait station with bait. Next to this rodent bait station our investigator observed what appeared to be four (4) rodent excreta pellets.”
- “Our investigator observed two (2) dead cockroaches, dirt, and pieces of dead insects on the floor of the warehouse next to pallets of finished products for distribution such as “Sazón con Culantro y Achiote” (Seasoning (redacted)) (redacted)oz., “Agrandador de Sabor” ((redacted)) (redacted)oz., food ingredients, and packaging materials. Additionally, a dead cockroach was observed on the floor of the production area next to a sink used for cleaning equipment and a mop and bucket used to clean the facility.”
- “Our investigator observed a live fly inside of a (redacted)lb. (redacted) jar that an employee stated is used during repacking and comes into contact with spices. In the same area, an employee was repacking by hand “Agrandador de Sabor” ((redacted)) (redacted)oz. for which there were open jars and exposed finished product.”
- “In close proximity to the production and packing areas, our investigator observed an accumulation of waste, wooden pallets, old paperwork, materials, and equipment in disuse which could serve as harborage and breeding areas for pests. Additionally, accumulated dust and fine product particles which could attract rodents and insects were observed on surfaces throughout the facility.”
- “There was poor or no illumination in the warehouse where pallets of finished products and packaging materials were stored. In addition, pallets were stored against the walls. These conditions prevent your firm from properly inspecting for rodent and pest activity.”
“The following areas lacked protection against the entry of pests:”
- “A screen gate leading from the outside of the plant to the interior of the warehouse and processing areas had gaps along the bottom and sides that ranged from (redacted) to (redacted) inches wide, providing ingress of insects and other pests into the processing area and other areas of the plant. Outside this gate was a dumpster, which can attract rodents and insects.”
- “There was an opening approximately (redacted) inches wide on a wall of the production area, which led to the exterior of the facility. A window screen covering this opening was detached from the wall, leaving your production facility exposed to the entry of pests.”
“Your response indicates that your firm hired a third party to provide pests control services. However, your response does not address the other deficiencies cited, including the gaps and openings observed throughout the facility, which allow the entry of pests and the poor illumination observed at the warehouse. Further, you do not indicate whether any measures will be implemented to prevent recurrence of the deviation, such as routine inspections of the facility to detect the presence of pest activity.”
- “You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR Part 117.80(c)(2). In addition, you did not maintain equipment and utensils and food containers in an adequate condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 117.80(c)(1).”
- “During production, employees (redacted) An employee identified (redacted) on all exterior surfaces of the mixer and other manufacturing equipment. The brushes were also used in the interior (food contact) surfaces of the mixer without being cleaned and sanitized before use. Your employee stated (redacted).”
- “(redacted) production employees used dirty fabric mittens during (redacted) of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) and repacking of “Agrandador de Sabor” ((redacted)). The mittens showed orange-colored stains that an employee identified (redacted) Your employee informed (redacted) Between uses, these mittens were exposed to the environment and in direct contact with dirty surfaces throughout the facility. Specifically, your employees used mittens for handling dirty surfaces, such as the corroded parts of the (redacted) drum used to collect ingredients, the forklift, dusty bags of ingredients, the brushes used to clean up the mixer, and plastic containers. These mittens were also used in the interior (food contact) surfaces of the mixer and capper machine without being cleaned and sanitized before use.”
- “During the packaging activities of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) an employee lubricated the machinery of a (redacted) machine wearing the fabric mittens and using a non-food grade lubricant oil. The same employee grabbed paper towels impregnated in oil and then handled the lids that were used to cap finished products. The employee did not remove the mittens and perform hand washing before touching the food contact surfaces of the lids. The employee wore the fabric mittens while touching dirty wooden pallets and a knife that was used to cut open carton boxes. In addition, the oil can was stored in the capper machine, along with the exposed products being packed.”
- “Employees used filthy and deteriorated (redacted) containers (trash cans) lined with a dirty reused blue (redacted) bag for holding the finished blend of “Sazón con Culantro y Achiote” (Seasoning with (redacted)) until packaging took place. Our investigator observed your employees placing and dragging these containers throughout the dirty production area floor. An employee also stated (redacted) Our investigator also observed that the (redacted) bags were stored on dirty (redacted) pallets against a dirty and corroded (redacted) rack before being reused inside the containers with the seasoning.”
- “An employee formulating “Sazón con Culantro y Achiote” (Seasoning with (redacted)) did not handle ingredients properly so as to prevent contamination during the addition of ingredients to the mixer. He did not clean the dust on the exterior of the bags of monosodium glutamate and salt before opening them. He also placed and dragged the bags of ingredients throughout the dirty production area floor. The employee then placed the bags inside of a (redacted) drum and tapped the bags with his hands to empty them. The (redacted) drum used to collect the ingredients was corroded and dusty; the lining was made of non-food grade plastic tape that was flaking. This tape could come off when ingredients are discharged from the drum, contaminating the finished product with plastic fragments. Our investigator observed dark particles that appeared to be rust fall from the corroded drum’s surface onto the ingredients in the mixer when the employee lifted the drum with a forklift and discharged its contents.”
- “Dirty and deteriorated (redacted) containers showing scratches and discoloration were used to hold ingredients such as egg yellow shade colorant, coriander, garlic, black pepper, and cumin. Some of these containers were not labeled to identify their contents. Employees used shared dirty scoops to collect these ingredients. These practices could contribute to the contamination of treated spices with pathogenic microorganisms.”
- “Employees used a deteriorated filthy razor to cut and open the packages of ingredients. The razor had a customized handle made with pieces of cardboard and tape. These practices expose your food to physical hazards (e.g. metal fragments and other potentially hazardous foreign matter) and microbial hazards.”
- “A yellow apron used in the manufacturing operations was hanging against a dusty wall and a dirty working table with spider webs.”
- “Throughout the processing area and warehouse, you had toxic compounds (e.g., paint, roof sealer, non-food grade lubricants and degreasers, gasoline, herbicides, pesticides, and rodenticides) gardening equipment and tools, garbage, empty dirty buckets, waste left by your employees (e.g., empty dirty coffee cups) and employees’ personal belongings (e.g., boots, bags, and lunchboxes). All these items were improperly stored next to or near where in-process and finished products were exposed.”
- “You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials maintain cleanliness by washing their hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR Part 117.10(b)(3). Specifically, (redacted) employees were observed not washing their hands or changing their gloves after using their cell phones or returning to their working stations after changing tasks. An employee packaging “Sazón con Culantro y Achiote” (Seasoning with (redacted)) went to the bathroom with his gloves on, returned to his work station, and continued working wearing the same gloves. The employee changed his gloves when our investigator called his attention to the deficiency, but our investigator did not observe him re-washing his hands before donning new gloves. Our investigator observed that these employees had a box of disposable gloves available to change their gloves during manufacturing activities without having to go to the handwashing sink to re-wash their hands.”
- “You did not provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature, as required by 21 CFR Part 117.37(e). Specifically, your firm’s hand-washing facilities lacked hot water, paper towels or another suitable drying device.”
- “You did not provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage, as required by 21 CFR Part 117.20(b)(5). Specifically, several light fixtures did not have covers and/or shatter proof bulbs so that their light bulbs remained exposed over the food and packaging materials stored below. These conditions expose your food products to potential glass contamination.”
- “You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices by wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(6). Specifically, (redacted) of your employees were observed not wearing beard nets during production and packaging. of the employees were working on the formulation of “Sazón con Culantro y Achiote” (Seasoning with (redacted)), and (redacted) was packaging the finished ready-to-eat product. Also, an employee was observed not wearing his hair restraint correctly, which left part of his hair exposed.”
- “You did not ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials remove unsecured jewelry and other objects that might fall into food, equipment, or containers to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(4). Specifically, an employee was observed wearing three stud earrings on his left ear.”
“Your response indicates that preventive controls will be implemented according to the FSP developed by your consultant. You did not provide any documentation of measures that will be implemented to assure conformance with CGMPs and how your firm will prevent these violations from recurring while the FSP is developed. In addition, you did not provide documentation or a timeframe of when and how the corrections it will be implemented.”
- “Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because it fails to bear a Nutrition Facts label, as required by 21 CFR Part 101.9.”
- “Your Tugusto Chef Sazón con Culantro y Achiote and Tugusto Bijaol Condimento Para Sabor y Color products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but they do not bear labels that include a complete list of all the ingredients by common or usual name, as required by 21 CFR Part 101.4.”
a.” Your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (redacted) however, it fails to list the sub-ingredients “(redacted)” and (redacted). If the silicon dioxide ingredient serves as a chemical preservative and the term “anticompactante” (anticaking) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). Additionally, your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (redacted) however, it fails to list the sub-ingredient “(redacted)”.”
b. “Your Tugusto Bijaol Condimento Para Sabor y Color product is manufactured using (redacted) but fails to declare these ingredients. Furthermore, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare all sub-ingredients of the multicomponent ingredient (redacted) including (redacted) Additionally, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients of the multicomponent ingredient (redacted). If the (redacted) ingredient serves as a chemical preservative and the term “(redacted)” ((redacted)) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). You stated during the inspection that your Tugusto Bijaol Condimento Para Sabor y Color product (redacted) Your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients (redacted) or (redacted) as appropriate.”
c. “Your Tugusto Chef Sazón con Culantro y Achiote and Sazón Tugusto Agrandador de Sabor products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the product labels bear the nutrient content claims “40% Menos Sodio Que La Sal (40% Less Sodium Than Salt)” and “60% Less Sodium Than Salt,” respectively, but fail to declare clear and concise quantitative information comparing the amount of sodium per declared serving in the products to that of the reference food (salt) as required by 21 CFR Part 101.13(j)(2)(iv) and 21 CFR Part 101.61(b)(6)(ii)(B). This statement shall appear adjacent to the most prominent nutrient content claim on the information panel.”
d. “Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. The product label declares “Harina de Maíz” (Cornmeal), “Pimentón” (Red Pepper), and “Glicol de Propileno” (Propylene Glicol) as ingredients although these ingredients are not part of the product’s formulation.”
A complete list of the violations can be found in the FDA’s warning letter.