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.
Raw Juicery Inc.
Los Angeles
A juice company in Los Angeles is on notice from the FDA for serious violation of the food code, notably, the firm did not identify patulin as a hazard likely to occur in their HACCP plan.
In a June 11 warning letter the FDA described a Nov. 6 and 12, 2019, inspection at Raw Juicery Inc.’s facility. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation.
The significant violations are as follows:
The firm’s HACCP plan must list all food safety hazards that are reasonably likely to occur. A “food hazard” is defined as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, the firm’s HACCP plan does not identify the food hazard of patulin. The FDA noted that the firm’s hazard analysis for Juice Blends, identified patulin as a hazard likely to occur. When an identified food hazard is determined to be reasonably likely to occur, the food hazard must be addressed in a HACCP plan.
The full warning letter can be viewed here.
Diamond Rock Food Imports Inc.
Copiague, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 8 warning letter the FDA described a March 9 Foreign Supplier Verification Program (FSVP) follow-up inspection at Diamond Rock Food Imports Inc.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:
- Tomato Sauce manufactured by (redacted)
- Refried Red Beans manufactured by (redacted)
- Grape Soft Drink manufactured by (redacted)
The full warning letter can be viewed here.
H & C Food Inc.
Brooklyn, NY
A food company in Brooklyn is on notice from the FDA for not having FSVPs for imported Enoki Mushroom and Teriyaki Kimnori Roasted seaweed from South Korea.
In a June 22 warning letter the FDA described an April 9 and 14 Foreign Supplier Verification Program (FSVP) follow-up inspection at H & C Food Inc.
The FDA’s inspection revealed that the firm was in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:
The firm did not meet their requirements to conduct a hazard analysis for their Enoki Mushroom imported from Green Co., Ltd., located in South Korea and their Teriyaki Kimnori Roasted seaweed Snack imported from (redacted) Specifically, the firm did not document their review and assessment of their foreign supplier’s hazard analysis. The FSVP regulation also generally requires that they evaluate their foreign supplier’s performance and conduct foreign supplier verification activities, among other requirements.
The full warning letter can be viewed here.
El Abuelito Cheese Inc.
Paterson, NJ
A cheese company in New Jersey is on notice from the FDA after inspectors found non-pathogenic Listeria species in its manufacturing facility.
In a June 4 warning letter the FDA described a Jan. 14 through Feb. 6, inspection at El Abuelito Cheese Inc.’s ready-to-eat cheese manufacturing facility. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
The FDA’s inspection resulted in issuance of an FDA Form 483a. The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
- The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically, the firm did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control. Their facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Listeria monocytogenes is an environmental pathogen that is a known or reasonably foreseeable hazard for cheeses, in particular soft cheeses such as queso fresco.
- The firm did not establish 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 their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. For example, for the processing of RTE foods exposed to the environment, generally sanitation controls are needed to control environmental pathogens such as Listeria monocytogenes. Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.
- They did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in their facility. A food safety plan must include the following:
- The written hazard analysis;
- The written preventive controls;
- The written supply-chain program;
- The written recall plan;
- The written procedures for monitoring the implementation of the preventive controls;
- The written corrective action procedures;
- The written verification procedures.
The firm’s response indicates that they are working with a HACCP consultant to develop their food safety plan for their facility. The FDA will assess the adequacy and implementation of their food safety plan during the next FDA inspection.
In addition to the violations described above, the FDA offered the following comments:
- During their inspection, the FDA collected environmental swabs from various locations throughout their processing areas. FDA laboratory analysis of the environmental sample INV1123037 collected on January 15, 2020 confirmed two (2) swabs positive for Listeria grayi and Listeria innocua; both are non-pathogenic Listeria species (Listeria spp.). One of the positive swabs was collected from a surface adjacent to a food-contact surface on the (redacted) edges of the (redacted) conveyor belt. Additionally, FDA laboratory analysis of the environmental sample INV1123040 collected on January 29, 2020 confirmed one (1) swab positive for Listeria innocua. The presence of Listeria spp. indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in their facility. The firm only tests their environment for ATP and coliforms; they do not conduct swabbing for Listeria spp., which is an appropriate indicator organism for Listeria monocytogenes. As noted above, Listeria monocytogenes is a known or reasonably foreseeable hazard for cheese; sanitation controls are generally applied to prevent contamination of RTE food such as cheese from the environment, and environmental monitoring for Listeria spp. is usually used to verify these controls.
- During FDA inspection, investigators made observations regarding the potential need for the monitoring of certain aspects of their operation, which would need to be assessed when their firm evaluates the need to establish and implement preventive control programs. Specifically, they do not monitor their sanitizer solution to ensure concentration levels are effective for their (redacted) sanitizer at the production entry door, their (redacted) of sanitizer containing white rags used to wipe down equipment, or their buckets of sanitizer used to soak utensils.
- The FDA notes that part 117 includes requirements for training employees and keeping records of certain training. The firm’s response states that they (redacted). However, their response does not include details on when this (redacted) will occur or the records documenting that this (redacted) was conducted. The FDA will verify the adequacy during their next inspection.
The full warning letter can be viewed here.
Global Commodities Corp.
Hayward, CA
A food company in California is on notice from the FDA for not having FSVPs for imported Boy Bawang Mixed Nuts Snacks-Garlic, Buenas Kaong Red Sugar Palm Fruit in syrup, and Macapuno String in Syrup Preserves.
In a June 3 warning letter the FDA described a Feb.27 Foreign Supplier Verification Program (FSVP) follow-up inspection at Global Commodities Corp.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:
Significant violations of the FSVP regulation are as follows:
- The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for Boy Bawang Mixed Nuts Snacks-Garlic manufactured by KSK Food Products, Philippines.
- For a low-acid canned food not subject to further processing, the firm did not verify and document the food was produced accordance with the low-acid canned food regulations, or with respect to all matters not controlled by part 113, they did not have an FSVP. Specifically, the firm did not document compliance with 21 CFR part 113 or otherwise develop an FSVP for Buenas Kaong Red Sugar Palm Fruit in syrup and Macapuno String in Syrup Preserves manufactured by (redacted), Philippines.
The full warning letter can be viewed here.
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