Inspections, Compliance, Enforcement, and Criminal Investigations
Productos Alimentios Centroamericanos, S.A. 7/2/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
July 2, 2013
VIA EXPRESS DELIVERY
Ms. Ileana Bustamante
Owner and General Manager
Productos Alimenticios Centroamericanos S.A.
28 Calle 0-31, Zona 3
Guatemala City, Guatemala
Reference No. 396542
Dear Ms. Bustamante:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at 28 Calle 0-31, Zona 3, Guatemala City, Guatemala on February 11-12, 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 114)) and the current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food (cGMP) regulation (21 CFR 110). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We have not received any correspondence from your firm in response to the FDA-483 indicating that you have corrected the problems.
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. Regulations specific to the processing of acidified foods are described in 21 CFR 108, Emergency Permit Control and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 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 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a 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. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified 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, the acidified food regulations, and the cGMP regulations through links in FDA’s home page at http://www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to manufacture acidified food in accordance with the filed scheduled process as required by 21 CFR 114.80(a)(1). Specifically, your firm’s filed scheduled process for Hot Peppers Sliced and Marinated (b)(4) lists a (b)(4) a critical factor. Your firm is currently only using a (b)(4) in practice.
2. Your firm failed to employ appropriate quality control methodology to determine pH for your product as required by 21 CFR 114.90(a)(6). Specifically, your firm was not (b)(4) of the Hot Peppers Sliced and Marinated product before testing the finished (b)(4) value of the finished product. Your firm was only testing the (b)(4) portion of this product.
3. Your firm failed to have all operators of processing and packaging systems under the operating supervision of a person who has attended a school approved by the Commissioner as required by 21 CFR 114.10.
4. Your firm failed to, not later than 60 days after registration, and before packing any new product, provide the FDA information on the scheduled processes as required by 21 CFR 108.25(c)(2). Specifically, your firm continued to manufacture and export soy sauce to the United States after your submitted scheduled process (b)(4) had been returned on June 6, 2012.
5. You failed to construct your plumbing so as to avoid constituting a source of contamination to food, water supplied, equipment or utensils as required by 21 CFR 110.37(b)(3). Specifically, several hoses that transfer in-process food ingredients were observed throughout the processing areas of the facility touching floors and in standing water; further, several hose stations throughout the processing areas of the facility were observed without any type of backflow prevention.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 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 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 and all applicable regulations, including the acidified food regulations (21 CFR 108 and 114) and the cGMP regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Carol D’lima, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 #396542 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.
Office of Compliance
Center for Food Safety
and Applied Nutrition