Department of Health and Human Services
|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
December 30, 2015
WARNING LETTER NO. 2016-NOL-01
UNITED PARCEL SERVICE
Delivery Signature Requested
Teresa C. Bennett, Owner
1717 City Avenue North
Ripley, Mississippi 38663
Dear Mrs. Bennett:
During September 23-24, October 6 and 9, 2015, United States Food and Drug Administration (FDA) investigators inspected your seafood processing facility, located at 1717 City Avenue North, Ripley, Mississippi. This inspection 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 regulation for foods, Title 21, Code of Federal Regulations, Part 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 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 United States Code (USC) 342(a)(4)]. Accordingly, your fishery products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby theymay 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 letter dated October 20, 2015, responding to the FDA 483, Inspectional Observations issued to you on October 9, 2015. This letter will become part of your official file. Your response is inadequate because you have not implemented corrective actions or provided substantive proof of the corrective actions to be taken at your facility. Violations revealed during the inspection include, but are not limited to:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish or fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for any of the fishery products you produce (these include: fresh catfish, frozen shrimp, frozen oysters, and frozen crawfish tails) which are received, stored, and distributed by your firm. Your firm also hasn’t conducted a hazard analysis for any of these fishery products to control the food safety hazards of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
2. You must monitor the conditions and practices during processing with sufficient frequency to ensure conformance with current Good Manufacturing Practices, as required by 21 CFR 123.11(b). The following was noted during the inspection:
- You must provide safety-type light bulbs or fixtures suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. However, uncovered breakable light bulbs in your firm’s (b)(4) and freezer were observed directly over frozen catfish, shrimp, and crawfish tails.
- You must have sufficient space for the placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. However, cases of frozen catfish were observed stored directly against the wall in the (b)(4) freezer.
- You must have adequate floor drainage in all places where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor. However, a build-up of frozen condensate was observed on the floor under the fans in the (b)(4) freezer.
- You must ensure that rubbish be so convened, stored, and disposed of as to minimize the potential for the waste becoming an attractant and harborage or breeding place for pests and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces. However, the following was observed: tires, trash, and debris were observed stored in the (b)(4) cooler; a bathroom toilet, old equipment, and trash were observed located in the storage area between the dock doors and the (b)(4) cooler; and, trash, debris, old equipment, tires, and vehicles not in use were observed outside and surrounding the facility.
- You must have adequate screening or other protection against pests where necessary. However, a hole was observed at the base of the dock door which provided a possible entry way for a pest.
- You must ensure that weeds or grass are cut within the immediate vicinity of the plant. However, tall grass and weeds were observed surrounding the facility.
3. You must maintain sanitation control records that, at a minimum, document the monitoring and corrections you make as a result of monitoring the sanitary conditions and practices that are appropriate for your plant, as required by 21 CFR 123.11(c). However, your firm was found not to be maintaining records for the following: the safety of the water that comes into contact with food or food contact surfaces, including water used to manufacture ice; the condition and cleanliness of food contact surfaces; the prevention of cross contamination from insanitary objects; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; the control of employee health conditions; and, for the exclusion of pests.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that 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.
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 Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: David Van Houten, Compliance Officer, at the above address. If you have questions, concerning the contents of this letter, you may contact Mr. Van Houten at (615) 366-7813.
Ruth P. Dixon
New Orleans District