Inspections, Compliance, Enforcement, and Criminal Investigations
Comercializadors Albino S.A. de C.V. 05-Oct-04
Department of Health and Human Services
Public Health Service
October 5, 2004
Mr. Albino Lizarraga Lizarraga
Comercializadora Albino S.A. de C.V.
Pto. Salina Cruz, Lote 1-A, Planta Baja
Parque Industrial Alfredo V. Bonfil
Dear Mr. Lizarraga Lizarraga,
This is to acknowledge receipt on August 12, 2004 of your letter dated July 28, 2004, along with your revised HACCP plan for frozen, raw headless shrimp, supporting documents, and photographs, in response to our June 18, 2004 letter.
Our review of your firm's revised HACCP plan determined that your firm's HACCP plan remains inadequate. Although some revisions to the HACCP plan are acceptable, the main deviation brought to your attention in our June 18, 2004 letter, remains uncorrected. Specifically, your firm's HACCP plan fails to list the food safety hazard of sulfites in the Reception critical control point.
The headless shrimp received by your firm comes from diverse origins; namely, ocean-caught, farm-raised, and estuaries/bays, as revealed during inspection on March 1 & 2, 2004, and identified in your original HACCP plan. However, your original HACCP plan only listed the "Presence of Sulfitings agents" food safety hazard at the 'CCP 4 Received Fresh Shrimp from Farm' critical control point; whereas, the revised HACCP plan only lists the "Presence of sulfites" hazard at the 'CPC 3 Primary packing (sheathe)' critical control point. Please be advised that undeclared sulfites is a hazard that should be controlled and monitored at the Reception stage regardless of the origin of shrimp as the shrimp are further processed on the vessels.
We recommend one of several critical limits for controlling sulfites in incoming shrimp at the receiving step, for example, "Incoming lots of shrimp must not contain a detectable level of sulfite"; "Incoming lots of shrimp must be accompanied by a supplier's lot-by-lot certificate that sulfiting agents are not used"; or "the labeling or shipping documents for incoming lots of shrimp received from another processor must not contain a sulfiting agent declaration," to name a few.
Please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 19 (Allergens/Food Intolerance Substances), found at www.cfsan.fda.gov/~comm/haccp4.html for specific guidance, control strategies, and sample HACCP plans for your review.
We have concluded that your factory continues to operate with the same significant deviation found at the time of our inspection. Consequently, we are placing your firm's frozen headless shrimp on Import Alert #16-120, immediately. As a result, when these products are offered for import into the United States, FDA may take steps to refuse their admission, called Detention Without Physical Examination (DWPE).
FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. This procedure is generally based on past history and/or other information such as an establishment inspection report indicating that the factory producing the product and/or the product itself may not be in compliance with FDA's laws and regulations.
If you wish to request removal from Import Alert #16-120, "Detention Without Physical Examination Of Fish And Fishery Products Where The Foreign Processor Has Failed To Comply With Seafood HACCP, 21 CFR 123," you should address the deviations described above. Your response should outline the specific steps you are taking to correct these deviations. You should include in your response, documentation such as a copy of your re-revised HACCP plan for frozen headless shrimp, reflecting the changes you made, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations is also welcome.
You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the 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 Food and Drug Administration, Attention: Giselle Jordan, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Import Branch HFS-606, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Jordan at (301) 436-1576 or via e-mail at email@example.com.
Judith A. Gushee
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition