Inspections, Compliance, Enforcement, and Criminal Investigations
Tico's Mexican Foods, Inc. 12/21/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
December 21, 2010
Ref: DEN-11-05 WL
Mr. Clyde Canino, Owner
Tico's Mexican Foods, Inc.
2011 South Bannock Street
Denver, Colorado 80223
Dear Mr. Canino:
We inspected your firm, Tico's Mexican Foods, Inc., located at 2011 South Bannock Street, Denver, Colorado, on September 21-23, 27, 2010. Our inspection found that your firm has serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 [21 CFR Part 123]. In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR Part 123 renders the 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). Accordingly, your clam chowder 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 FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
The deviations that were found during the inspection were as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process 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 clam chowder to control the potential food safety hazards of pathogen growth and toxin formation, including potential for Clostridium botulinum toxin development and allergens.
We received your written response dated October 11, 2010 to the FDA 483, Objectionable Observations, on October 14, 2010. Our review of the information provided in that response reveals that it is inadequate. While you state that you will write an interim HACCP plan using the principles of your fully-cooked, not-shelf-stable HACCP plan, you have not, as of this time, provided a HACCP plan (or plans) to address the hazards and controls associated with the above mentioned product. Furthermore, you state that the General Manager will enroll in the Seafood Alliance Internet Training Course as soon as FDA approves this response. During this time, the temporary HACCP plans will be amended to reflect the requirements of the seafood regulations. However, you are currently responsible for ensuring that your processing plant operates in compliance with the seafood regulations.
For additional information and guidance concerning the hazards of pathogen growth, including Clostridium botulinum growth and toxin formation; pathogen survival through cooking; post processing contamination; and allergens, please refer to chapters 12, 13, 16, 18 and 19 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response, documentation such as your HACCP plans, any records required to document your HACCP plan including temperature monitoring records, cook steps including cooking temperatures, corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all of the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Good Manufacturing Practice regulations (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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
H. Thomas Warwick, Jr.
Denver District Director