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WARNING LETTER

Johnson Sea Products, Inc. MARCS-CMS 510532 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Lyle S. Johnson
Recipient Title
President
Johnson Sea Products, Inc.

8210 Pirtle Street
Coden, AL 36523-0665
United States

Issuing Office:
New Orleans District

United States


November 18, 2016

WARNING LETTER NO. 2017-NOL-02


Dear Mr. Johnson:

On August 22, 23, 25, and 26, 2016, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 8210 Pirtle Street, Coden, Alabama. We found 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 (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Parts 123 and 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan which 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 United States Code (USC) 342(a)(4). Accordingly, your ready-to-eat crabmeat and stuffed seafood products are adulterated because 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 on FDA's Internet home page at www.fda.gov.

We acknowledge receipt of your written response, dated September 1, 2016, to the deviations observed during the inspection and listed on the FDA 483 issued to you on August 26, 2016. We have evaluated your response and discuss your corrective actions relative to each item below.

The significant violations were as follows:

1) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen survival when your process for cooked crabs deviated from your critical limit at the cooking critical control point. Specifically, your written HACCP plan for Fresh Picked crab meat states you would cook crabs at a (b)(4) for a minimum of (b)(4); however, a review of your (b)(4) Cook Log demonstrates you did not take corrective action that ensured the affected product was segregated, a review of the affected product was done to determine its acceptability, affected product was not entered into commerce, and the cause of the deviation was corrected:

a. On August 17, 2016, Cook (b)(4) was (b)(4) short of the (b)(4);
b. On May 28, 2016, Cook (b)(4) was (b)(4) short of the (b)(4);
c. On January 19, 2016, Cook (b)(4) was (b)(4) short of the (b)(4); and,
d. On November 30, 2015, Cook (b)(4) was (b)(4) short of the (b)(4).

You explained in your written response you trained your employees of the cooking times, record keeping, and you conducted a review of the records .. In addition, you state you purchased a stop watch to monitor the cooking time. Although you begin to address our concerns, you failed to address your assessment of the crabmeat released into commerce which may have received an inadequate cook time, or the results of your record review.

2) You must implement the monitoring procedures and frequency you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring of the temperature of the cooler at least (b)(4) when product is stored in the cooler at "Backed Crab and Claw Cooling" and "Finished Product Storage" critical control points to control pathogen growth and toxin formation listed in your HACCP plan for ready-to-eat crab meat. Specifically, you have no cooler monitoring records for when product was stored in the cooler on Sundays from November 2015 until August 22, 2016.

You explained in your written response you modified your HACCP plan and a non-production cooler log was developed for the recording of cooler and product temperatures. Your HACCP plan list a frequency of "(b)(4) When Not in Production". According to the current HACCP guidelines, if the adequacy of ice surrounding the product is being monitored during refrigerated storage, monitoring should be conducted with "sufficient frequency to ensure the critical limit is met" and should be based on products in the cooler rather than production schedules.

3) 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 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

a. On August 23, 2016, an employee repeatedly contacted the inside of a dirty trash container then contacted cooked crabs/cooked crab parts and the backing table without washing/sanitizing his hands between contacts.
b. On August 23, 2016, during crabmeat picking/packing operation, three live flies were observed in the picking/packing room. The flies were observed to land on unsanitary objects such light bulbs, trash containers and the wet floor. The flies were also observed to land on the picking table and cooked crabs.
c. At least six (6) unprotected light bulbs were observed in the picking/packing area over or near food or food contact surfaces.

You explained in your written response that you instructed picking employees to wash and sanitize their hands after they touched insanitary objects. You did not provide any records documenting the training provided to your employees. You also explain in your response that you instructed employees to (b)(4) to minimize the chances of flies entering the facility and you purchased (b)(4) to prohibit the entry of flies. You also explained that you covered light bulbs with covers to reduce the chance of contaminating your food products and packaging from foreign substances. Although these corrective actions begin to address the Agency's concerns, the implementation of those measures will be evaluated during an inspection to be conducted at a later date.

This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You are responsible for preventing further violations of the Act and all applicable regulations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations. We are aware you voluntarily destroyed the bags of "(b)(4)" observed to contain insects and rodent excreta pellets noted above; and, withdrew the crabmeat stuffed jalapeno peppers made with this ingredient from the market. You should include in your response documentation such as sanitation records, or other useful information which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Section 743 of the Act, [21 USC 379j-31], authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31 (a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, 404 BNA Drive, Building 200- Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 846-6103.

Sincerely,
/S/

Ruth P. Dixon
District Director
New Orleans District