Inversiones Himalaya S.A 6/15/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD

June 15, 2011

WARNING LETTER

VIA OVERNIGHT MAIL

Mr. Jorge Castro Ruiz
Canned Fish Manager
Inversiones Himalaya S.A.
No S/N Zona Industrial De Sechura
Costado Enosa
Sechura - Piura, Peru

Reference #182152

Dear Mr. Ruiz:

FDA inspected your facility Inversiones Himalaya S.A. located at No S/N Zona Industrial De Sechura, Costado Enosa, Sechura - Piura, Peru on January 27-28, 2011. We found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of section 404 of the Act; and, particularly, implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your low-acid canned food 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 canned seafood is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA's home page at http://www.fda.gov.

Your significant violations were as follows:

• Your firm could not provide thermal distribution studies for (b)(4) as required by 21 CFR 113.40(a)(12)(iii). Specifically, you could not provide evidence in the form of heat distribution data supporting that your retorts installed in September 2010 accomplish adequate venting of air if they deviate from the specifications of 21 CFR 113.40(a)(12)(i).

• Your firm is not monitoring and recording processing and production information as required by 21 CFR 113.100(a). Specifically, inspection revealed that you are not monitoring and recording the critical factor of particle size in Seafood Mix (b)(4). Review of processing records also revealed that your firm might not be adequately controlling the critical factors fill wt., drained wt. and drained to net wt. ratios in these and other products that you manufacture.

We acknowledge receipt of your firm's response dated February 18, 2011 via email from Mr. Enrique Rodriguez to FDA in regard to the deviations identified during the inspection. Your response included sanitation control programs, pest controls and fumigation records and photographs, standard operating procedures, HACCP records, photographs of employee good manufacturing practice (GMP) training and production and quality records. Our evaluation concludes that you have satisfactorily responded to the food GMP observations. However, your response did not address the two violations discussed above. In order to help us expedite our review of any further information that you may submit, we ask that you provide the information in English.

You should respond in writing within thirty (30) 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 that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported low-acid canned food products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on 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. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA's web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.

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 low-acid canned food regulations (21 CFR Part 108 and 113), 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Greaves at (240) 402-2057 or via email at Donald.Greaves@fda.hhs.gov.

Sincerely,

/s/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
 

-