Productos del Convento, S.A. de C.V. 2/6/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||5100 Paint Branch Parkway|
College Park, MD 20740
February 6, 2012
VIA OVERNIGHT DELIVERY
Reference No. 266975
Mr. Benjamin Martinez Morales
Productos del Convento, S.A. de C.V.
Avenida Cinco, No. 253,
Colonia Granjas San Antonio,
Dear Mr. Morales:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned foods facility, Productos del Convento, S.A. de C.V, located at Avenida Cinco No. 253, Colonia Granjas San Antonio, Mexico City, Mexico on August 22 – 23, 2011. During that inspection, we found that your firm had serious deviations from the low-acid canned foods regulation (21 CFR Part 113) 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 low-acid canned food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of low-acid canned food products that you export to the United States. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108) and Part 113, Low-Acid Canned Foods (21 CFR 113). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR Part 113 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)). 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 firm manufactures “Chongos Zamoranos,” an LACF product, in multiple container sizes.
Your significant violations are as follows:
1. Your firm did not process each low–acid canned food in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i). Specifically, the processing records for your “Chongos Zamoranos” product in a container size of (b)(4) showed that the product received a (b)(4) However, the scheduled process filed with FDA for this product has a (b)(4)
2. Contrary to established venting requirements, your firm’s process timing began before the retort was properly vented and the processing temperature was reached as required by 21 CFR 113.40(a)(12). Specifically, your “Chongos Zamoranos” products in container sizes (b)(4) were retorted without reaching a (b)(4)
3. Your firm did not determine and record the initial temperature of the contents of a container to be processed with sufficient frequency to ensure the temperature was not lower than the minimum initial temperature stated in the filed scheduled process as required by 21 CFR 113.87(c). Specifically, the processing records for all product sizes and types of your “Chongos Zamoranos” product did not include the initial temperature, a critical factor.
4. Your firm failed to identify, from processor check or otherwise, deviations from the filed scheduled process or critical factors which are out of control as required by 21 CFR 113.89. Specifically, during the inspection, our investigator observed the following deviations from the filed scheduled process and these were not included in the firm’s deviation file:
a. “Chongos Zamoranos” in a container size of (b)(4) received a (b)(4) whereas, the scheduled process filed with FDA for this product shows that the (b)(4).
b. “Chongos Zamoranos” in container sizes (b)(4) were retorted without reaching a (b)(4)
5. Your firm did not post operating processes for each product and container size in a conspicuous place near the processing equipment and readily available to the retort or processing system operator as required by 21 CFR 113.87(a). Specifically, during the inspection the scheduled processes for the “Chogos Zamorranos” for container sizes (b)(4) were not posted in a place where they were readily available to the retort operator.
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 and prevent their recurrence. Your response should include 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 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 low-acid 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.accessdata.fda.gov/cms_ia/ialist.html.
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). 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, Compliance 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 #2000020276 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