|Company:||Nick & Katie's Inc.|
|Subject:||Seafood/HACCP/CGMP for Foods/Adulterated|
|Issuer:||New Orleans District Office|
|Issued:||June 17, 2008||Closed:||
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
June 17, 2008
WARNING LETTER NO. 2008-NOL-16
DELIVERY SIGNATURE REQUESTED
Mrs. Janet T. Ruffino, President
Nick & Katie's, Inc.
6845 Louis XIV
New Orleans, Louisiana 70124-3331
Dear Mrs. Ruffino:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 5325 Franklin Avenue, Suite A, New Orleans, Louisiana on February 6, 7, and 13, 2008. We found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations , Part 123 (21 CFR 123), and the Current Good Manufacturing Practice regulation for foods, 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 to comply 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), Section 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 contaminated and 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 .
Violations requiring your immediate attention are as follows:
• You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product which 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 stuffed crabs, crab stuffed mushrooms, stuffed bell peppers, and crayfish stuffed portabella mushrooms to control the food safety hazards of pathogen survival, growth and toxin formation and allergens.
• You must maintain sanitation control records which, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). Your firm did not maintain sanitation monitoring records for the safety of water which comes in contact with food or food contact surfaces; condition and cleanliness of food contact surfaces; the prevention of cross-contamination; the maintenance of hand washing facilities; the protection of food from adulteration with lubricants, fuels and pesticides, etc.; the proper labeling, storage and use of toxic compounds; the control of employee health conditions; and, the exclusion of pests from the food plant as required for the processing of your ready-to-eat fishery products.
We may take further regulatory action if you do not promptly correct these violations. For
instance, we may seize your product(s) and/or enjoin your firm from operating.
We acknowledge you voluntarily recalled finished product with labels which failed to list the three allergenic ingredients wheat, soy and milk. You promised to correct the allergen listing on all your labels. We received corrected labels for your Stuffed Italian Artichoke and Crab Stuffed Mushrooms. We have not received corrected labels for your remaining stuffed products including, Crayfish Stuffed Portabella Mushroom, Stuffed Crab, Stuffed Bell Pepper, Cocktail Muffaletta, Artichoke Balls, and Mediterranean Stuffed Artichoke.
The FDA request a written response within fifteen (15) working days from your receipt of this letter outlining the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and verification records, corrected labels, or other useful information which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, state the reason for your delay and 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 also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Hardin at 504-219-8818, extension 102.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483 dated February 13, 2008