Inspections, Compliance, Enforcement, and Criminal Investigations
Dean Blanchard Seafood, Inc. 2/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
February 9, 2011
WARNING LETTER NO. 2011-NOL-09
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Dean P. Blanchard, President
Dean Blanchard Seafood, Inc.
195 Cypress Lane
Grand Isle, Louisiana 70358-9653
Dear Mr. Blanchard:
We inspected your seafood processing facility, located at 195 Cypress Lane, Grand Isle, Louisiana on October 26 and November 2,2010. 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 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 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 fish 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.
Your significant violations were as follows:
1. You must implement the record keeping system listed in your HACCP plan to comply with 21 CFR 123.6(b). However, your firm did not maintain harvest vessel records at the receiving critical control point to control scrombotoxin formation, as listed in your HACCP plan for scrombotoxin forming fish.
2. You must have a HACCP plan that at a minimum, lists the critical limits which must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "King Mackerel, Amberjack, Bar Jack, Wahoo, Mahi-mahi" does not list the sensory examination and internal temperature critical limits at the receiving critical control point to control scombrotoxin formation.
In addition to requiring harvest vessel records, FDA recommends you conduct a sensory examination of a representative sample of fish (i.e., 118 fish in the lot or all of the fish if the lot consists of less than 118 fish) to ensure no more than 2.5% decomposition in the lot; and, you monitor the internal temperatures of a representative number of incoming fish to ensure the lot of fish is at or below 40°F.
3. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "King Mackerel, Amberjack, Bar Jack, Wahoo, Mahi-mahi" does not list the critical control point of cooler storage for controlling the food safety hazard of scombrotoxin formation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation such as your revised HACCP plans, harvesting records, sanitation records, and verification records, or other useful information to assist us in evaluating your corrections. 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 Current Good Manufacturing Practice 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, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Kimberly L. McMillan
Acting District Director
New Orleans District