- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMark D. Mavar
- Biloxi Freezing & Processing, Inc.
260 Maple St.
Biloxi, MS 39530
- Issuing Office:
- Division of Human and Animal Food Operations East V
WARNING LETTER 648616
March 16, 2023
Dear Mr. Mavar:
The FDA inspected your seafood processing facility, located at 260 Maple St., Biloxi, MS 39530 on November 08 through 21, 2022. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR 123 & 117). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your individually quick frozen (IQF) shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Further, we have reviewed the product labels collected during the inspection and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.
1.You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your HACCP plan for M&M Shrimp IQF, including the Planned Verification Activities document fails to list verification procedures required under 21 CFR 123.8(a) at any of your 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. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 117, to comply with 21 CFR 123.11(b). However, your firm did not monitor safety of water with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 117 as evidenced by a water hose used to wash food contact surface observed on November 8, 2022, stored partially submerged in water on the floor. The water hose was also not connected to a backflow prevention device. Further, your firm did not monitor proper labeling, storage, and use of toxic compounds with sufficient frequency to ensure compliance with 21 CFR Part 117 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 November 8, 2022.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not have a record identified as “(b)(4)” as required by your 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. Your 16/20 Raw IQF Headless Brown Shrimp product is misbranding within the meaning of section 403(i)(2) of the FD&C Act [21 U.S.C. § 343(i)(2)] in that the labeling fails to declare the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically, the product label declares the ingredient “tripoly;” however, tripoly is not a common or usual name. We note that if the intended ingredient is “Sodium Tripolyphosphate” then it should be declared as such under 21 CFR 182.1810. 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 in accordance with 21 CFR 101.22(j) (e.g., “Sodium Tripolyphosphate (to retain moisture)”).
2. Your 31/40 product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that it fails to bear the common or usual name of the food, as required by 21 CFR 101.3. Specifically, “31/40” is not an appropriate statement of identity for shrimp.
3. Your 16/20 Raw IQF Headless Brown Shrimp product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that it fails to bear the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d). Specifically, the product label only includes the name of the distributor. Under 21 CFR 101.5(d), 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.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
We also offer 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, “(b)(4) Form,” lists (b)(4). That or similar information should be listed in the CCP#2 monitoring procedures. [21 CFR 123.6(c)(4)]
- 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 your 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. [21 CFR 123.6(c)(1)]
- 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. [21 CFR 123.7(b)(2)]
- We note that your 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. In accordance with 21 CFR 101.4, 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 exempted by 21 CFR 101.100, and the preservative function of the Sodium Bisulfite must be declared in accordance with 21 CFR 101.22(j).
- We note that the term “shrimp” in the statement of identity for your 16/20 Raw IQF Headless Brown Shrimp product does not meet the requirements in 21 CFR 101.15(a) and lacks prominence as specified in 21 CFR 101.3(d).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East