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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cal Valls 6/11/12

  

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

Public Health Service
Food and Drug Administration
 College Park, MD
 

JUN 11, 2012

WARNING LETTER

VIA EXPRESS DELIVERY

Mr. Daniel Valls
Production and Quality Manager/Secretary
Cal Valls
Carni La Plana S/n
Vilanova de Bellpuig
Spain

Reference No.: 304079

Dear Mr. Valls:

The U.S. Food and Drug Administration (FDA) inspected your acidified foods facility, Cal Valls, located at Carni La Plana, S/n, Vilanova de Bellpuig, on January 26-27, 2012. During that inspection, we found that your firm had serious deviations from the Acidified Foods regulation (Title 21, Code of Federal Regulations, Part 114 (21 CFR Part 114)) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). Further, our review of the labels for your BIO Asparagus (LACF asparagus spears in glass jars) and Piquillo Whole Peppers (acidified Piquillo peppers) in conjunction with the information obtained during our inspection revealed that these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.

The inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the deviations from the regulations in 21 CFR Part 108, Emergency Permit Control; Part 114, Acidified Foods; and Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food identified by our investigator during the inspection.

We acknowledge that your firm submitted a response to the FDA-483 on February 13, 2012, and your corrective actions appeared to adequately address the Current Good Manufacturing Practice (CGMP) deviations. In response to the acidified foods deviations concerning your olive products, we recommend that you submit revised scheduled process filings to FDA for further evaluation as it appears from the information available to us at this time that you may be re-packing a fermented olive product, which may be excluded from the acidified foods regulations. Determination of the product's regulatory status as an acidified or fermented product is crucial to evaluating your firm's compliance status for such products. Our low-acid canned and acidified foods technical office can make that determination if you submit further product and process information. We encourage you to use the electronic submission portal:

http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/ElectronicSubmissions/default.htm

Label Review

Our review of the labels for your "BIO Asparagus" and "Piquillo Whole Peppers" products identified that the products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the labels do not bear the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5(c). Specifically, the labels for your "BIO Asparagus" and "Piquillo Whole Peppers" products state that they are produced by "V·V" S.A.T. n° 1717, Cami la Plana s/n., 25264 Vilanova de Bellpuig, Catalonia, Spain"; however, our inspection revealed that these products are processed by a contract manufacturer at a separate location.

The contract manufacturer (b)(4) is not  registered with FDA as an Low-Acid Canned Food or Acidified Food manufacturer, and they do not have scheduled processes on file for these two products as required by 21 CFR 108. Moreover, your firm has been using your FCE and SID numbers for purposes of shipping these products for entry into the United States.

Your "BIO Asparagus" and "Piquillo Whole Peppers" products are also misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels bear information in a foreign language, but not all required information is declared in both the foreign language and English. The requirements under 21 CFR 101.15(c) state that if any representation is made on a label in a foreign language, all the required information must be presented in both the foreign language and in English.

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 further 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 fifteen working 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 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 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 you firm operates in compliance with the Act, the Acidified Food regulations (21 CFR Part 108 and 114), the food labeling regulation (21 CFR Part 101), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. 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: Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 Ms. Jones at (240) 402-2575 or via email at robyn.jones@fda.hhs.gov.

Sincerely,

/s/

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