FDA warns two food companies in China over seafood violations in facilities

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.


Hainan Golden Spring Foods Co. Ltd.
China 

A food firm in China is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In a May 4 warning letter, the FDA described a Dec. 13-15, 2021, inspection of Hainan Golden Spring Foods Co. Ltd’s seafood processing facility in Meilan Qu, Haikou Shi, Hainan Sheng, China.

The FDA’s inspection revealed that the firm was not in compliance with HACCP regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:

The firm must implement the monitoring and verification procedures and frequency that they have listed in their HACCP plan. However, the firm did not follow monitoring and verification procedures for every lot at the (redacted) critical control point to control aquaculture drug residues listed in their HACCP plan for raw frozen reduced oxygen packed tilapia fillets, dated March 7, 2021. Specifically,

a. Their production records for finished product lot # (redacted) (redacted) lists a total of (redacted) drug residue testing results under the (redacted) method conducted by their laboratory between Aug. 17 to Aug. 28, 2021. FDA investigators reviewed their laboratory’s (redacted) FC equipment use log and found only (redacted) tests were run between the same timeframe.

b. Their production records for finished product lot # (redacted) (redacted) lists a total of (redacted) drug residue testing results under the (redacted) method conducted by their laboratory between Nov. 16-26, 2021. FDA investigators reviewed their laboratory’s (redacted) FC equipment use log and found only (redacted) tests were run in the same timeframe.

The firm could not explain the discrepancy because its laboratory does not keep sample preparation records. The laboratory employees estimated that (redacted) percent of the test on the testing reports for 2020 and 2021 were actually conducted. FDA investigators discussed this with them during the inspection closeout meeting. In their response submitted on Jan. 5, 2022, they stated their corrective actions would include implementing HACCP plan CCP1 monitoring and verification activities. They submitted a revised HACCP plan, dated Dec. 20, 2021, and monitoring records for five consecutive days running from Dec. 27-31, 2021. The FDA acknowledges that the revised HACCP plan includes a verification procedure to “(redacted)” and provided an inter-laboratory comparison and verification report with their response. However, the FDA has determined that its response is inadequate. Their laboratory comparison report only compares a single test from a single lot for (redacted), which is not a representative sample. Furthermore, their report does not show that their test kits can detect aquaculture drugs at the reported level (redacted) ug/kg as compared to the national standard method used in external laboratories.

The full warning letter can be viewed here.

Zhoushan Haichang Co. Ltd.
China 

A food firm in China is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

In a May 9 warning letter, the FDA described a March 3-4, 2022, inspection of Zhoushan Haichang Co. Ltd.’s seafood processing facility in Shenjiamen, Putuo District Zhoushan, Zhejiang, China.

The FDA’s inspection revealed that the firm was not in compliance with HACCP regulations and resulted in the issuance of an FDA Form 483. The significant deviations are as follows:

1. The firm must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. However, the firm’s HACCP plan for Frozen (cut) swimming crab does not list the critical control point of labeling to control the food safety hazard of sulfites. Their current plan lists a (redacted) critical limit for sulfites that allows acceptance of crabs with residues up to (redacted) ppm. FDA requires the declaration of the presence of sulfites when sulfite residues are 10 ppm or greater on labels and a critical control point to assure accurate labeling. If they choose not to declare the presence of sulfites on their labels and establish a critical control point in their plan, FDA recommends adjusting their current receiving critical limit to exclude raw material swimming crabs with residues of 10 ppm or greater.

2. The firm must conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, the firm’s HACCP plan does not list the food safety hazard of allergens associated with the frozen cut swimming crab (crustacean).

3. They must monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with the current good manufacturing practice requirements. The firm failed to monitor with sufficient frequency the 8 key areas of food safety as demonstrated:

a. Safety of water as required. During the inspection, there were debris and residue in water used to produce ice.

The full warning letter can be viewed here.

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