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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mexican Products & Spice Company 6/26/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

June 26, 2012
 
2012-DAL-WL-027
 
 
WARNING LETTER
 
                                                                                                           
UPS OVERNIGHT
 
 
Enedelia L. Galván, Owner
Mexican Products and Spice Company
24040 North FM 506
La Feria, Texas 78559
 
                                                                                               
Dear Ms. Galván,
 
We inspected your seafood processing facility, located at 24040 North FM 506, La Feria, Texas, on May 17 - 21, 2012. We found that you have serious violations 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 shrimp products 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, the seafood HACCP and labeling regulations, 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:
 
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 repacked dried shrimp products to control the food safety hazard of undeclared sulfiting agents. In addition, you do not have controls in place for this hazard. 
 
According to the bulk shrimp label, it may contain the food safety hazard sodium bisulfite, a sulfiting agent. Sulfites are known to cause intolerance reactions in sensitive individuals. Sensitive individuals can experience symptoms ranging from mild to life-threatening, including tingling sensations in the mouth, hives, digestive upset, swelling of the tongue and throat, and difficulty in breathing. A declaration of the presence of sulfites in the ingredient declaration is essential to alert sensitive individuals to its presence. While we recognize that your current labels contain such a declaration, there are no ongoing control measures in a HACCP plan to assure that the declarations appear in the labeling.
 
We acknowledge receipt of your letter postmarked June 12, 2012, which states you have conducted a hazard analysis and are planning to complete your seafood HACCP training this summer. However, you have not yet provided a HACCP plan.
 
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
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 and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
 
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
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.
 
Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.
 
                                                                       
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
Cc:     
Phillip C. Galván, Manager
Mexican Products and Spice Company
24040 North FM 506
La Feria, Texas 78559