As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not sent to the public until weeks or months after dispatch. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not sent out until a company has had months to years to rectify problems.
A food company in Nicaragua has been notified by the FDA of serious violations of the HACCP Regulation (Hazard Analysis and Critical Control Point).
In a warning letter on June 17, the FDA described a 7.-15. February 2022 Foreign Remote Regulatory Assessment (FRRA) by Nicamex Seafoods Seafood Processing Plant in Managua, Nicaragua.
The FDA’s assessment revealed serious violations of the HACCP regulation for shellfish.
Some of the significant violations:
The company must have a HACCP plan that at least sets out the critical limits to be met. A critical limit is defined as “the maximum or minimum value to which a physical, biological or chemical parameter must be checked at a critical checkpoint to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” the company’s HACCP plan for dried sea cucumber has a critical limit, “(edited),” at the (edited) critical control point, which is not sufficient to control pathogenic bacterial growth and toxin formation. Specifically, the critical limit does not ensure that finished product is 0.85 or less to control the food safety risk of Staphylococcus aureus (S. aureus) Drying the product sufficiently to reduce the water activity to 0.85 or less is essential to obtain a safe end product. minimal water activity for toxin formation of S. aureus. gsa inhibit the growth of other microbiological hazards. The FDA recommends that the company establish the drying parameters using a scientific validation study to ensure that the final product consistently achieves a water activity of 0.85 or less. Once all parameters have been 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 safe water activity in their finished product, they must implement time and temperature control to prevent S. aureus growth and toxin formation before achieving a water activity of 0.85. The FDA recommends that treatment temperatures be kept below 10 ° C (50 ° F) during processing and stored refrigerated, either surrounded by ice or kept below 4.4 ° C (40 ° F). In the absence of cooling, exposure to uncontrolled temperatures should be limited to 3 hours cumulatively if ambient temperatures at any time exceed 21 ° C (70 ° F). When the temperature remains between 10 ° C (50 ° F) and 21 ° C (70 ° F), safe exposure times can be extended to 12 hours cumulatively.
2. The company must implement the registration system that they have specified in their HACCP plan. However, their company did not implement the registration system set out in their HACCP plan for dried cucumbers. Specifically, on 02/08/2022, under FRRA of their facility, the investigator requested HACCP monitoring records for the processing of their dried sea cucumbers, which were shipped to the United States on 30/06/2021, 05/05/2021, and 21 / 04/2021. On 14/02/2022, they informed the investigator via email that they are unable to provide the requested records as these were not found in the files of their archive collection center.
3. The company must implement and maintain sanitary inspection records to comply. However, they do not implement sanitary inspection registers documenting the monitoring and corrections of sanitary deficiencies for the safety of water coming into contact with food or food contact surfaces; condition and cleanliness of surfaces in contact with food; prevention of cross-contamination from sanitary items; maintenance of washbasins, hand sanitizers and toilet facilities; protection of food, food packaging materials and food contact surfaces against counterfeiting; proper labeling, storage and use of toxic chemicals; control of employees’ health conditions; and exclusion of pests. Specifically, on 02/08/2022, the investigator requested sanitary monitoring registers for the treatment of dried sea cucumbers on 30/06/2021, 05/05/2021 and 21/04/2021. On 14/02/2022, the investigator received an email from the company’s general manager stating that he was unable to provide the requested records as he could not find these in their archive collection center files.
The full warning letter can be seen here.
SDJJ Distributors National City, CA.
An import company in California has been notified by the FDA for not having FSVPs for a number of imported foods.
In a warning letter of June 6, 2022, the FDA described an 11-18. January 2022, FSVP (Foreign Supplier Verification Program) inspection of SDJJ distributors in National City, CA.
The FDA inspection revealed that the company did not comply with the FSVP rules and resulted in the issuance of an FDA Form 483a. The significant infringements are as follows:
The company developed, maintained and did not follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
The full warning letter can be seen here.
An import company in Texas is notified by the FDA not to have FSVPs for a number of imported foods.
In a warning letter of June 9, 2022, the FDA described a 7.-15. March 2022, Foreign Supplier Verification Program (FSVP) inspection by Winfull Corporation in Houston, TX.
The FDA inspection revealed that the company did not comply with the FSVP rules and resulted in the issuance of an FDA Form 483a. The significant infringements are as follows:
1. The company developed, maintained and did not follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
2. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid preserves), and for the microbiological hazards associated with those foods, the company must verify and document that they have been produced in accordance with the Regulation. Specifically, they did not verify and document that the canned goods 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 (concerning thermally processed low acid foods packaged in hermetically sealed containers ), as required.
The full warning letter can be seen here.
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