Inspections, Compliance, Enforcement, and Criminal Investigations
Noxubee County Producers Inc. (dba Superior Fish Products) 4/29/10
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
April 29, 2010
WARNING LETTER NO. 2010-NOL-12
United Parcel Service
Delivery Signature Requested
Norman Koehn, Chairman of the Board
Noxubee County Producers, Inc.
11751 Highway 45
Macon, Mississippi 39341
Dear Mr. Koehn:
On December 7, 10, and 16, 2009, an U.S. Food and Drug Administration (FDA) investigators inspected your seafood processing facility, located at 11751 Highway 45, Macon, Mississippi. 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, 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 which complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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 catfish is adulterated because they have been prepared, packed, or held under insanitary conditions whereby it 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.
We are in receipt of an undated written response from (b)(7)(C) Health and Safety Director, received on February 9, 2010, concerning our investigators' observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to Fredrick L. Johnson, General Manager, on December 16, 2009. We address this response below, in relation to each of the noted violations.
After review of your HACCP plan for raw catfish products collected during the inspection, we observed the following deviations:
1. You must have a HACCP plan which, at a minimum, lists the monitoring procedures for each critical control point (CCP), to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for raw catfish products list a monitoring frequency at the receiving CCP which is not adequate to control aquaculture chemicals and drugs. The monitoring frequency at the receiving CCP, listed as "(b)(4)" and (b)(4)" is not adequate to control the hazard of aquaculture chemicals and drug residues in your catfish. Because you control aquaculture chemical and drug usage in your catfish by obtaining certificates from the catfish growers, you must obtain a certificate for each lot of catfish received. FDA recommends you list the frequency in your HACCP plan to obtain a certificate for each lot of catfish received in your facility.
2. You must verify your HACCP plan is adequate to control food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, the verification procedure "(b)(4)" is not adequate to verify the catfish do not contain unsafe levels of chemical contaminants and/or drug residues. FDA recommends you perform the following:
a. Visit all new aquacultured fish suppliers within the year and all existing fish suppliers at a predetermined frequency to review the grower's drug usage procedures; or,
b. Collect a representative sample of the raw material, in-process product, or finished product at least quarterly and analyze it for drug residues.
Furthermore, you must review monitoring, corrective action and verification records within one week of preparation.
3. Because you chose to include a corrective action plan in your HACCP plan for raw catfish products, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions listed at the "Receiving live catfish" CCP to control aquaculture chemicals and drugs is not adequate because it does not insure the cause of the deviation is corrected. In addition to rejecting the affected lot, FDA recommends you discontinue the use of the catfish supplier until evidence is obtained assuring the supplier will comply with the established source control policies.
The following violations were noted during the inspection:
4. You must implement the record keeping system you have listed in your HACCP plan for raw catfish products to comply with 21 CFR 123.6(b) and (c)(7). However, you failed to follow the monitoring procedure of receiving certificates, which guarantee chemical contaminants and/or drug residues in the catfish are within FDA guidelines and regulations, from each grower at the receiving critical control point. Specifically, you failed to obtain certificates for (b)(4) catfish growers which supply the catfish.
(b) (7)(C) explains in his response you now have (b)(4) catfish growers which supply your catfish; however, you have received certificates from (b)(4) growers.
5. You must maintain sanitation control records which, at minimum, document monitoring and corrective actions to comply with 21 CFR 123.11(c). However, you failed to document corrective actions taken when your spiral freezer failed the pre-operation sanitation check on July 20, 2009.
(b)(7)(C) explains in his response employees are documenting the actions taken to correct deviations noted during sanitation inspections. He failed to explain your actions to assure this deviation does not recur.
6. You failed to document the calibration of the thermometers, as required by 21 CFR 123.8(d). Specifically, you have no records documenting the calibration of thermometers used on a daily basis to determine the temperature of your finished product cooler and freezer holding catfish products.
(b)(7)(C) explains in his response you are now monitoring the thermometers on a daily basis and are calibrating them properly; however, he failed to provide documentation demonstrating the thermometers were calibrated.
(b)(7)(C) provided your HACCP plan for lemon pepper marinade catfish as part of the response dated February 9, 2010. After further review of your HACCP plan, we observed the following:
• Your firm's HACCP plan for lemon pepper marinade catfish does not list the CCPs at the receiving step, to control the hazard of aquaculture drugs and chemicals, and at the processing and packaging steps, to control the hazard of metal inclusion.
• The corrective action listed at the "Weigh, Pack, Label" CCP to control the hazard of undeclared additives is not appropriate because they do not insure the cause of the deviation is corrected. FDA recommends you address the label disposition and/or product disposition of the misbranded product as a corrective action to control allergens.
• You must verify your HACCP plan is adequate to control food safety hazards which are reasonably likely to occur, to comply with 21 CFR 13.8(a). However, the verification procedure "(b)(4)" at "Weigh, Pack, Label" CCP is not adequate to verify your allergen control procedures. Verification of allergen controls should include conducting the review within one week of performing the label inspection.
We reviewed the labels provided with (b)(7)(C) correspondence and note the statement of identity for your Lemon Marinade stick-on label should read:
Catfish with Lemon Pepper Marinade
Ingredients: Catfish, Sodium Tripolyphosphate, Sodium Chloride, Spices, Onion, Garlic, Corn Syrup Solids, Citric Acid, Xantham Gum, Lemon solids, Natural Lemon Flavor, and FD&C Yellow No.5 .....
We question the use of the ingredient statement on the 15 lbs (6.8kg) box which reads in part: "Catfish, Water, Sodium Tripolyphosphate, Salt... " when using the Lemon Pepper Marinade stick-on label. You cannot have two ingredient statements on your product. We recommend you cover or remove the ingredient statement on the 15 lbs (6.8kg) box which reads in part: "Catfish, Water, Sodium Tripolyphosphate, Salt... " when using the Lemon Pepper Marinade stick-on label. Should you plan to use the Spicy Cajun Marinade stick-on label, we recommend you make the same suggested changes to your labeling.
We may take further action if you do not promptly correct these violations, including seizure of your product(s) and/or enjoin your firm from operating. We recognize Mr. Fredric L. Johnson, General Manager, made a verbal commitment to correct the observed deficiencies at the close of the inspection on December 16, 2009.
You should respond in writing, within fifteen (15) working days from receipt of this letter, of the specific steps you have taken to correct the noted violations. You should include in your response documentation such as your revised HACCP plan, verification records, or other useful information to assist us in evaluating your collections. If you cannot complete all corrections within 15 days, 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 CGMP regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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.
H. Tyler Thornburg
New Orleans District
Enclosure: FDA 483
Health and Safety Director
Superior Fish Products
P.O. Box 700
Macon, MS 39341