Inspections, Compliance, Enforcement, and Criminal Investigations
Landshire, Inc 1/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
January 17, 2012
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Joseph E. Trover, Jr., Chief Executive Officer
727 N. 1st Street
St. Louis, MO 63102
Dear Mr. Trover:
We inspected your seafood processing facility, d/b/a Mom's Food Products Inc., located at 4117 Garland Drive, Fort Worth, Texas, on September 8-22, 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, (21 CFR 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 Ready-to-Eat Tuna Salad Sandwiches are adulterated, in that they had 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 in FDA's home page at www.fda.gov.
Your significant violation was 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 the manufacturing of Ready-to-Eat Tuna Salad Sandwiches to control the food safety hazard of Clostridium botulinum.
We may take further action if you do not promptly correct the violation. For instance, we may take further action to seize your product(s) 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. We acknowledge representatives of your management staff have confirmed a regulatory meeting with Dallas District on January 26, 2012 at 10:00a.m. Central Standard Time. You may submit your written response and any documentation of corrective action during that meeting.
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 Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ronda Loyd-Jones at 214-253-5242.
Reynaldo R. Rodriquez Jr.
Dallas District Director
cc: Susan R. Jubela, Site Manager
4117 Garland Drive
Fort Worth, Texas 76117