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.

PT. Winson Prima Sejahtera

A food firm in Sumatera Utara North Sumatra, Indonesia is on notice from the FDA for violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, including a HACCP plan that does not list the food safety hazard of pathogen growth.

In a Sept. 5, 2023, warning letter, the FDA described an April 2-9, 2022, a Foreign Remote Regulatory Assessment (FRRA) of PT. Winson Prima Sejahtera’s seafood processing facility.

The FDA’s inspection found that the firm had serious violations of the Seafood HACCP regulation. At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, your firm has not responded to the discussion items identified during the FFRA.

Some of the significant violations are as follows:

1. The firm must conduct or have conducted a hazard analysis for their wild, frozen, vacuum packaged, ready-to-eat yellowfin tuna 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, to comply with regulation. 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 pathogen growth, including Salmonella, which can be introduced during (recalled) processing steps for their ready-to-eat raw tuna products (e.g., ground tuna, saku, tuna chunks). Cumulative time exposures should be limited to 2 hours when ambient temperatures (e.g., water, air) are not controlled and/or exceed 21.1 degrees celsius (70 degrees fahrenheit) to prevent pathogen growth.

2. The firm must have a HACCP plan that at minimum lists the critical limits that must be met, to comply with regulation. A critical limit is defined as the “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 lists a critical limit “(redacted)” at the (redacted) critical control point that does not provide the necessary safety assurance needed to prevent histamine formation as required. FDA recommends listing critical limits that address the ambient temperature (e.g. air, water) in the storage area to assure the safety of all fish units.

3. The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan, to comply with regulation and (redacted). The firm’s HACCP plan lists a monitoring procedure “(redacted)” at the receiving critical control point (CCP) to control scombrotoxin (histamine) formation. However, they are not implementing the recordkeeping system, monitoring procedures, or maintaining the necessary monitoring records as required. Specifically,

    a. Their records show that internal temperatures were not consistently monitored at receiving CCP. For example, their “(redacted)” from Supplier (redacted) showed the internal temperatures were missing for No. 4, 5, 6 and for supplier (redacted) No. 3. Also, the Receiving Raw Material record dated 31/7/22 No. 74 – 108 was missing internal temperatures.

4. Since the firm chose to include corrective actions in their HACCP plan, their corrective actions must be appropriate, to comply with regulation. However, their corrective actions at the (redacted) critical control point for histamine testing, decomposition, and internal temperatures, are not adequate to ensure that affected product is not entered into commerce and that the cause of the deviation was corrected as required. Specifically,

    a. The corrective action listed “(redacted)”, does not list controls that address correcting the cause of the critical limit deviations.
    b. The corrective action lists “(redacted)” for (redacted) fish that will be tested for histamine does not include a statement that none of the fish tested should have histamine levels at or above (redacted) ppm.
    c. The firm’s monitoring records dated from Aug. 01-20, 2022 corresponding to their corrective action “(redacted)” do not show when they implemented the corrective action, in response to their critical limits of “(redacted)” being exceeded. For example, the Histamine Test Result records showed their critical limits were exceeded, specifically:
      i. Aug. 06, 2022 for Group (redacted) shows (redacted) ppm histamine
      ii. Aug. 04, 2022 for Group (redacted) shows (redacted) ppm histamine and Group (redacted) shows (redacted) ppm histamine
      iii. Aug. 03, 2022 for Group (redacted) shows (redacted) ppm histamine and Group (redacted) shows (redacted) ppm histamine. No records were provided to the investigator showing the retest results and whether the affected fish were effectively rejected.

The full warning letter can be viewed here.

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