| Public Health Service Food and Drug Administration |
| New Orleans District 404 BNA Drive Building 200 - Suite 500 Nashville, TN 37217 Telephone: (615) 366-7801 FAX: (615) 366-7802 |
Department of Health and Human Services
August 5, 2010
WARNING LETTER NO. 2010-NOL-18
United Parcel Service
Delivery Signature Requested
Lyle S. Johnson, President
Johnson Sea Products, Inc.
8210 Pirtle Street
Coden, Alabama 36523-0665
Dear Mr. Johnson:
On March 16-18,22 and 26, 2010, 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 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 in FDA's Internet home page at www.fda.gov.
A sample of (b)(4), collected during the inspection, was analyzed by FDA's Southeast Regional Laboratory (SRL). The SRL confirmed the presence of rodent gnawed holes and excreta pellets on multiple bags of this product and rodent excreta pellets in the contents of one bag while held at your facility. The presence of rodent excreta pellets in the breader causes your product to be adulterated within the meaning of Section 402(a)(3) of the Act, 21 USC 342(a)(3), because it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.
The significant violations were as follows:
1) You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the exclusion of pest with sufficient frequency to ensure control as evidenced by:
a. A lot of 30/35 lbs. bags of (b)(4) in the raw ingredient store room contained:
• 14 bags contained dead insects on top of the bags;
• 2 bags contained live insects on top of the bags;
• 1 bag contained rodent excreta pellets in the contents of the bag; and,
• 2 bags contained rodent gnawed holes.
b. At least 36 rodent excreta pellets were observed along the south wall of the raw ingredient storeroom.
c. A live fly was observed on the lid of a plastic tote containing clean crab shells in the processing room.
d. A hole was observed in the wall adjacent to the pallet of (b)(4) in the raw ingredient store room noted above.
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.
Please send your reply to the Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/s/
Kari L. Batey
Acting District Director
New Orleans District
Enclosure: FDA 483
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