Inspections, Compliance, Enforcement, and Criminal Investigations
Constanza Agroindustrial, S.R.I. 6/6/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20740
June 6, 2013
VIA EXPRESS DELIVERY
Mr. Felix Mercedes Guzman
Constanza Agroindustrial, S.R.I.
Av. 27 De Febrero No. 1515, Alameda
Santo Domingo Oeste
Reference No. 395358
Dear Mr. Guzman:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at Av. 27 De Febrero No. 1515, Alameda, Santo Domingo Oeste, Republica Dominicana on December 3 and 4, 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, Acidified Foods (21 CFR 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that listed the serious deviations found at your firm.
As a manufacturer of acidified 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 acidified food products for acidified foods that you export to the United States. These regulations 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 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 108.25 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 and the acidified food regulations through links in FDA’s home page at http://www.fda.gov.
We acknowledge receipt of your response dated April 3, 2013. In your response, you informed us of your GMP corrections, which were adequate. You also informed us that you had submitted a new process filing form to the agency with different critical factors; however, FDA has not received this submission. We further acknowledge your email dated May 2, 2012, providing copies of pH records and a statement that you would file a new scheduled process. We have not received further communication from you.
Your significant violations are as follows:
1. Your firm failed to manufacture acidified food in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, during the manufacture of Garlic Paste Constanza (SID 2009-04-29-001), your firm did not follow the hot fill temperature of (b)(4) for 9 oz. propylene jars. In addition, you did not invert the jars after filling to sterilize the headspace and lids. You mixed garlic paste ingredients in a steam jacketed kettle, (b)(4), and then cooled the mixture to (b)(4) before filling the jars. In addition, you used acetic acid instead of the citric acid that is listed in the SID.
In your response to the FDA-483, you indicated that you are now mixing the garlic paste and ingredients in a steam jacketed kettle, (b)(4); however, you have not yet filed this new process with FDA as required by 21 CFR 108.25(c)(2). Please note that this filing is required before packing any new product.
2. Your firm failed to exercise sufficient control including frequent testing and recording of results so that the finished equilibrium pH is not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, you did not establish the length of time needed for the acidified garlic paste to reach an equilibrium pH. In practice, you measured the pH of the garlic paste prior to filling and have not done studies to establish whether the pH changes after capping and sealing.
3. Your firm failed to maintain processing records showing adherence to the scheduled processes, including records of critical factors intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically, the thermal processing records for garlic paste such as the temperature and total process time were not complete. For example, you did not monitor the internal temperature of the garlic paste with a calibrated, submersible thermometer. You only monitored the temperatures at the surface during mixing with an infrared thermometer.
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 the acidified food regulations (21 CFR 108 and 114). 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 #395358 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