Inspections, Compliance, Enforcement, and Criminal Investigations
FFE Transportation Services, Inc 12/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 6, 2011
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Stoney M. Stubbs, Jr., CEO
FFE Transportation Services, Inc.
1145 Empire Central Place
Dallas, TX 75247-4309
Dear Mr. Stubbs:
We inspected your seafood processing facility, located at 3410 Stonewall Street, Lancaster, Texas 75134 on October 12-18, 2011. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. 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 U.S.C. § 342(a)(4). Accordingly, your canned pasteurized crabmeat is adulterated, in that it has 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 home page at www.fda.gov.
Your significant violation is as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that 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 canned pasteurized crabmeat to control the food safety hazard of C. botulinum.
In addition, in accordance with 21 CFR 123.10, at a minimum an individual at your firm must complete training in applications of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who is otherwise qualified through job experience to perform these functions. Your firm does not have anyone trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions.
We acknowledge your Warehouse Manager’s, Mr. Abraham Carrillo, verbal response to the observations made during the closeout of the inspection, in which he stated that your firm will (b)(4). However, no written documentation has been provided to verify this correction. 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 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 that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 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: Ronda Loyd-Jones, Compliance Officer at 4040 North Central Expressway Ste 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact Ronda Loyd-Jonesat 214-253-5242.
Reynaldo R. Rodriguez, Jr.
cc: Jerry H. Smith II, Service Center Manager
3410 Stonewall Street, Lancaster, Texas 75134