Inspections, Compliance, Enforcement, and Criminal Investigations
Conservas La Torre S.A. de C.V. 1/31/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
January 31, 2012
VIA EXPRESS MAIL
Reference No. 266796
Mr. Fernando Lorenzo Casal
Conservas La Torre S.A. de C.V.
Km 24.5 Carr. Puente de Vigas,
Tepotzotlan, Colonia San Lorenzo,
Dear Mr. Casal:
The U.S. Food and Drug Administration (FDA) inspected your acidified foods facility, Conservas La Torre S.A. de C.V, located at Km 24.5 Carr. Puente de Vigas, Tepotzotlan, Colonia San Lorenzo, Quautitlan Izcalle, Mexico on August 18 – 19, 2011. During that inspection, we found that your firm had serious deviations from the acidified food regulation (21 CFR Part 114) and emergency permit control regulation (21 CFR Part 108). The inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the serious deviations found at the firm. To date, we have not received any response from your firm with regard to the FDA Form 483 observations provided during our inspection.
As a manufacturer of acidified foods, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products that you export to the United States, Title 21, Code of Federal Regulations, Part 108 and 114 (21 CFR 108 and 114). Failure to comply with all the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 constitutes a basis for immediate application of the emergency permit control provisions of Section 404 of the Act and particularly implementation of 21 CFR 108.25(j) 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 Act, 21 U.S.C. 342(a)(4). Accordingly, your acidified food products are considered adulterated in that they have been prepared, packed or held under insanitary conditions where they may have been rendered injurious to health. You can find the Act and other relevant regulations through links in FDA’s Internet home page at http://www.fda.gov.
Your significant violations are as follows:
1. Deviations from your filed scheduled process were not recorded in a separate file or log that details both the deviations and the actions taken as required by 21 CFR 114.89. Specifically, your firm did not identify and record deviations from the filed scheduled process for various acidified products as observed in the following examples:
a. On March 24, 2011, your firm manufactured “Rodajas de Jalapeno” in 307 x 304 cans, with (b)(4) and a thermal process of (b)(4) The scheduled process for this product states the processing temperature and thermal process as 212 °F.
b. On September 13, 2010, your firm manufactured “Rajas de Jalapeno” in 603 x700 cans, with a processing temperature of (b)(4) a thermal process of (b)(4) The scheduled process for this product states the processing temperature and thermal process as 212°F, the IT as 104 °F and the processing time to be 10 minutes.
c. On May 5, 2010, your firm manufactured “Jalapeno” in 603 x 700 cans with a processing temperature of (b)(4) The filed scheduled process for this product states the processing temperature and thermal process at 212 °F and the processing time to be 10 minutes.
2. Failure to have personnel involved in acidification, pH control, heat treatment, and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the commissioner as required by 21 CFR 108.25(f).
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. In addition, responding in English will help to assist us in our review of your documentation. 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 to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified 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 acidified food regulations (21 CFR Part 108 and 114) 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 acidified food regulations (21 CFR Part 108 and 114). 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 Food and Drug Administration, Attention: Carol D’lima, Consumer Safety Officer, CFSAN Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov. Please reference FEI #3004254549 on any submissions and within the subject line of any emails to us. You may also contact Carol D’lima at (240) 402-2033 or email if you have any questions about this letter.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition