Inspections, Compliance, Enforcement, and Criminal Investigations
Mendoza Food Products, Inc. 29-Jan-08
Department of Health and Human Services
Public Health Service
January 29, 2008
RETURN RECEIPT REQUESTED
Mr. Martin Mendoza, President/Owner
Mendoza Food Products, Inc.
10203 Corkwood Place, Suite 115
Dallas, Texas 75238
Dear Mr. Mendoza:
We inspected your seafood processing facility, Mendoza Food Products, Inc. located at 10203 Corkwood Place, Dallas, Texas, on September 6, 7, 2007. We found that you have serious violations of the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, 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 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 dried and ground shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
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 dried shrimp and ground shrimp to control the food safety hazard of sulfites.
In addition, your dried El Gordo brand Whole Shrimp product (1oz) is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product is fabricated from two or more ingredients but fails to declare the common or usual name of each ingredient as specified under 21 CFR § 101.4. Specifically, according to your supplier's [redacted] bulk labels, this shrimp product also contains added salt.
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.
For your information when revising your product labels, please note the following:
• We note that the statements of identity for the two products referenced in this letter are "Whole Shrimp" and "Ground Shrimp." Under 21 CFR 101.3(b), the statement of identity should be an appropriately descriptive term of the food. Since these products are actually dried shrimp products, you may want to consider identifying the products as being "dried" as part of the statement of identity.
• We also note that some of the label information is provided in English and in an additional language. Under 21 CFR 101.15(c) all information required by or under the authority of the Act to appear on the label, shall appear thereon in English, and if any representation is made on the label in a foreign language, all the required information must also appear on the label in the foreign language.
Please 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 deviations. You should include in your response documentation such as your HACCP plan, copies of your labels, and 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 (214) 253-5220.
Elaine R. Crosby
Acting Dallas District Director