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.
Biloxi Freezing & Processing, Inc.
A food firm in Mississippi is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a March 16, 2023, warning letter, the FDA described a Nov. 8-21, 2022, FDA inspection of Biloxi Freezing & Processing, Inc.’s seafood processing facility in Biloxi, MS.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483.
1. The firm must verify that their HACCP plan is adequate to control food safety hazards that are reasonably likely to occur. However, their HACCP plan for M&M Shrimp IQF, including the Planned Verification Activities document fails to list verification procedures required at any of their critical control points to control sulfite declarations and allergen declarations. Ongoing verification procedures should include reviewing monitoring and corrective action records within one week of the day the records were made, calibration of equipment, and verification of the adequacy of critical limits. The firm did not verify the adequacy of the critical limits.
2. The firm must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements. However, the firm did not monitor safety of water with sufficient frequency to ensure compliance with the current good manufacturing practice requirements as evidenced by a water hose used to wash food contact surface observed on Nov. 8, 2022, stored partially submerged in water on the floor. The water hose was also not connected to a backflow prevention device. Further, the firm did not monitor proper labeling, storage, and use of toxic compounds with sufficient frequency to ensure compliance as evidenced by an observed two-gallon tank sprayer labeled as Roundup stored adjacent to food contact equipment, which contained an unidentified purple liquid on Nov. 8, 2022.
3. The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan and (redacted). However, the firm did not have a record identified as “(redacted)” as required by their HACCP plan for the monitoring of allergens at the Allergen Labeling critical control point (CCP#1) to control the crustacean allergen for IQF shrimp. Furthermore, the record identified as “1st Piece Inspection Form” states “Please assure label is correct and allergens (Shrimp and Sulfites) are clearly identified as it is our CCP#1.” However, the form does not provide space for monitoring observations showing the presence of shrimp and sulfites on the label instead of a non-specific allergen declaration.
1. The firm’s 16/20 Raw IQF Headless Brown Shrimp product is misbranded in that the labeling fails to declare the common or usual name of each ingredient. Specifically, the product label declares the ingredient “tripoly;” however, tripoly is not a common or usual name. FDA notes that if the intended ingredient is “Sodium Tripolyphosphate” then it should be declared as such. In addition, when an approved chemical preservative is added to a food, the ingredient list must include both the common or usual name of the preservative and the function of the preservative by including terms, such as “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor”, or “to promote color retention.” As such, if this ingredient is used as a preservative in the shrimp, then the function must be declared (e.g., “Sodium Tripolyphosphate (to retain moisture)”).
2. The firm’s 31/40 product is misbranded in that it fails to bear the common or usual name of the food. Specifically, “31/40” is not an appropriate statement of identity for shrimp.
3. The firm’s 16/20 Raw IQF Headless Brown Shrimp product is misbranded in that it fails to bear the place of business of the manufacturer, packer, or distributor. Specifically, the product label only includes the name of the distributor. The statement of the place of business must include the street address, city, state, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
FDA also offered the following comments:
- The plan lists an inadequate monitoring frequency “ongoing” at CCP#2 for controlling the hazard of sulfite inclusion. The listed frequency does not provide the necessary specificity for how often monitoring should occur. The monitoring record, “(redacted) Form,” lists (redacted). That or similar information should be listed in the CCP#2 monitoring procedures.
- CRITICAL CONTROL POINTS (CCP)/PREVENTIVE CONTROL (PC) DESCRIPTION document identifies the metal detector step as a preventive control point. It should be identified as a critical control point if the inclusion of metal fragments is determined to be a reasonably likely hazard in their hazard analysis. A hazard should be identified in the HACCP plan if it is reasonably likely to occur in the absence of controls. The hazard analysis erroneously determined that the metal detector (i.e., a control) made the hazard unlikely.
- The corrective actions for allergen labeling (CCP#1) and sulfiting declarations (CCP#2) address only the disposition of potentially affected products and do not address the cause of the critical limit deviations.
- FDA notes that their 16/20 Raw IQF Headless Brown Shrimp product label states “May Contain Sodium Bisulfite, Phosphate (Preservative).” Advisory statements may not be used in place of current good manufacturing practices or ingredients included in food. If these are ingredients or sub-ingredients added to the food, each ingredient must be declared in the ingredient list by its common or usual name (for example, sodium bisulfite, sodium phosphate, sodium tripolyphosphate) in descending order of predominance by weight unless, and the preservative function of the Sodium Bisulfite must be declared.
- FDA notes that the term “shrimp” in the statement of identity for their 16/20 Raw IQF Headless Brown Shrimp product does not meet the FDA requirements and lacks prominence as specified in FDA regulations.
The full warning letter can be viewed here.
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