The FDA warns food companies about violations of seafood and import regulations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to its competent entities. Some letters are not sent to the public until the week or month in which they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued to a company for months or years to correct problems.


Nicamex seafood
Nicaragua

A Nicaraguan food company has been warned by the FDA of serious violations of the Risk Analysis and Critical Control Point (HACCP) regulations.

In a warning letter dated June 17, the FDA described the Foreign Remote Regulatory Assessment (FRRA) of the Seafood Products Processing Facility in Nicamex Seafood, Managua, Nicaragua, from February 7 to 15, 2022.

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The FDA’s assessment revealed serious violations of seafood HACCP regulations.

Some notable violations:

1. The company must have a HACCP plan that lists at least the critical limits to be met. The critical limit is defined as “the maximum or minimum value that a physical, biological or chemical parameter must control at a critical control point to prevent, eliminate or reduce to an acceptable level the identified food safety risk. “However, the company’s HACCP plan lists a critical limit for dried sea cucumbers,”(writing)(writing) a critical control point that is not suitable for controlling the growth of pathogenic bacteria and the generation of the toxin. Specifically, the critical limit does not ensure that the maximum water activity of the finished product is 0.85 or less to control the risk of food safety. Staphylococcus aureus (S. aureus). Sufficient drying of the product to reduce water activity to 0.85 or less is essential to obtain a safe final product. This value is based on the minimum activity of water to generate toxins S. aureus. Achieving the aforementioned water activity will also prevent the growth of other microbiological hazards. The FDA recommends that the company set drying parameters using a scientific validation study to ensure that the final product will achieve continuous water activity of 0.85 or lower. Once all parameters have been validated, the critical factors for achieving the established water activity of less than 0.85 must be included as a Critical Limit in the HACCP plan.

In addition to achieving safe water activity in the finished product, they need to establish time and temperature controls to prevent it S. aureus growth and the creation of toxins before reaching a water activity of 0.85. The FDA recommends keeping processing temperatures below 10 ° C (50 ° F) while processing and storing them in the refrigerator, surrounded by ice, or below 4.4 ° C (40 ° F). When there is no cooling, uncontrolled temperature exposure should be limited to 3 hours if the ambient temperature exceeds 21 ° C (70 ° F) at any point. When temperatures are maintained between 10 ° C (50 ° F) and 21 ° C (70 ° F), the safe exposure time can be extended to 12 hours accumulated.

2. The company shall establish the registration system set out in the HACCP plan. However, his company did not establish a system for storing the records of their dried sea cucumbers in the HACCP Plan. Specifically, on 02/08/2022, at the FRRA of their facility, the researcher requested HACCP control records for the processing of dried sea cucumbers sent to the United States on 05/30/2021, 05/05/2021. and 2021/04/21. On 02/14/2022, the researcher was informed by e-mail that they could not provide the requested records as they were not found in the records collection center files.

3. The company must establish and maintain sanitation control records for compliance. However, no sanitation control records are established that document the monitoring and correction of water deficiencies in water safety that come into contact with food or food contact surfaces; The condition and cleanliness of surfaces in contact with food; prevention of cross-contamination from sanitary objects; maintenance of hand washing, hand washing 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 workers’ health conditions; and the elimination of pests. Specifically, on 08/02/2022, the researcher requested sanitation records for the processing of dried sea cucumbers on 06/30/2021, 05/05/2021 and 04/21/2021. On 02/14/2022, the researcher received an email from the CEO of the company stating that he could not provide the requested records as he could not find any records in the records collection center.

The full warning letter can be viewed here.

SDJJ distributors
National City, CA.

A California-based import company has been warned by the FDA that some imported foods do not have FSVP.

In a warning letter dated June 6, 2022, the FDA described the inspection of the Foreign Supplier Verification Program (FSVP) from January 11 to 18, 2022 as an inspection by the National City (CA) SDJJ Distributors.

An FDA inspection revealed that the company did not comply with FSVP regulations and issued FDA Form 483a. These are the most serious offenses:

The company did not develop, maintain and monitor an FSVP. Specifically, no FSVP was developed for each of the following foods:

  • Soft tamarind-mango flavored sweets (writing) imported from (writing) in (writing)
  • (Redacted) Caramel Mix imported from there (writing) in (writing)
  • (Redacted) Imported from Jilote (writing) in (writing)

The full warning letter can be viewed here.

Winfull Corporation
Houston, TX

An Texas import company has been warned by the FDA that some imported foods do not have FSVP.

In a warning letter dated June 9, 2022, the FDA described the inspection of Winfull Corporation’s Foreign Supplier Verification Program (FSVP) from March 7 to 15, 2022 in Houston, TX.

An FDA inspection revealed that the company did not comply with FSVP regulations and issued FDA Form 483a. These are the most serious offenses:

1. The company did not develop, maintain and monitor an FSVP. Specifically, no FSVP was developed for each of the following foods:

  • AA Grass Jelly Drink Drink Base (writing)located (writing)
  • Passion Fruit Pulp in Syrup (writing)located (writing)
  • Beans (writing)located (writing)

2. For thermally processed foods (low acid preserves) packaged in low acid containers, and for the microbiological risks associated with these foods, the company must verify and document that they have been produced in accordance with regulations. Specifically, they did not verify and document that the canned food products they import, such as AA Grass Jelly Drink Beverage Base and Kidney Beans, were produced in accordance with Section 21 CFR 113 (relating to thermally processed low-acid foods). in hermetically sealed containers), as required.

The full warning letter can be viewed here.

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