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.
Nicamex Seafood
Nicaragua
A food firm in Nicaragua is on notice from the FDA for serious violations of the Hazard Analysis and Critical Control Point (HACCP) regulation.
In a June 17 warning letter, the FDA described a Feb. 7-15, 2022 Foreign Remote Regulatory Assessment (FRRA) of Nicamex Seafood’s seafood processing facility in Managua, Nicaragua.
The FDA’s assessment revealed serious violations of the seafood HACCP regulation.
Some of the significant violations:
1. The firm must have a HACCP plan that, at a minimum, lists the critical limits that must be met. A critical limit is defined as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s HACCP plan for dried sea cucumber lists a critical limit, “(redacted),” at the (redacted) critical control point that is not adequate to control pathogenic bacteria growth and toxin formation. Specifically, the critical limit does not ensure that the maximum finished product water activity is 0.85 or below to control the food safety hazard of Staphylococcus aureus (S. aureus). Drying the product sufficiently to reduce the water activity to 0.85 or below is critical to obtaining a safe final product. This value is based on the minimum water activity for toxin formation of S. aureus. Achieving the above-mentioned water activity will also inhibit the growth of other microbiological hazards. FDA recommends that the firm establish the drying parameters utilizing a scientific validation study to ensure that the final product will consistently achieve a water activity of 0.85 or below. Once all the parameters are validated, the critical factors for achieving the established water activity of less than 0.85 should be included as Critical Limits in the HACCP plan.
In addition to achieving a safe water activity in their finished product, they must implement time and temperature controls to prevent S. aureus growth and toxin formation prior to achieving a water activity of 0.85. FDA recommends that processing temperatures be maintained below 10°C (50°F) during processing and stored under refrigeration, either surrounded by ice or maintained below 4.4°C (40°F). In the absence of refrigeration, exposure to uncontrolled temperatures should be limited to 3 hours cumulatively if ambient temperatures exceed 21°C (70°F) at any point. When temperatures remain between 10°C (50°F) and 21°C (70°F) safe exposure times can be extended to 12 hours cumulatively.
2. The firm must implement the recordkeeping system that they listed in their HACCP plan. However, their firm did not implement the recordkeeping system listed in their dried sea cucumber HACCP Plan. Specifically, on 02/08/2022, during the FRRA of their facility, the investigator requested HACCP monitoring records for the processing of their dried sea cucumbers that were shipped to the United States on 06/30/2021, 05/05/2021, and 04/21/2021. On 02/14/2022, they informed the investigator via email that they are not able to provide the requested records since these were not found in the files of their record collection center.
3. The firm must implement and maintain sanitation control records to comply. However, they are not implementing sanitation control records that document monitoring and corrections of sanitation deficiencies for the safety of water that comes into contact with food or food contact surfaces; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests. Specifically, on 02/08/2022, the investigator requested for the sanitation monitoring records for the processing of dried sea cucumbers on 06/30/2021, 05/05/2021, and 04/21/2021. On 02/14/2022, the investigator received an email from the firm’s General Manager stating that he is not able to provide the requested records since he could not find these in the files of their record collection center.
The full warning letter can be viewed here.
SDJJ Distributors
National City, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 6, 2022 warning letter, the FDA described a Jan.11-18, 2022, Foreign Supplier Verification Program (FSVP) inspection of SDJJ Distributors in National City, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Tamarind-Mango Flavored Soft Candy (redacted) imported from (redacted) in (redacted)
- (Redacted) Caramelo Mix imported from (redacted) in (redacted)
- (Redacted) Jilote imported from (redacted) in (redacted)
The full warning letter can be viewed here.
Winfull Corporation
Houston, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 9, 2022 warning letter, the FDA described a March 7-15, 2022, Foreign Supplier Verification Program (FSVP) inspection of Winfull Corporation in Houston, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
1. The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- AA Grade Grass Jelly Drink Beverage Base from (redacted), located in (redacted)
- Passion Fruit with Pulp Syrup from (redacted), located in (redacted)
- Kidney Beans from (redacted), located in (redacted)
2. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), and with respect to the microbiological hazards associated with these food products, the firm must verify and document that they were produced in accordance with regulation. Specifically, they did not verify and document that the canned food products they import, including but not limited to AA Grade Grass Jelly Drink Beverage Base and Kidney Beans, were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required.
The full warning letter can be viewed here.
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