Inspections, Compliance, Enforcement, and Criminal Investigations
Sabila SRL 7/1/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
July 1, 2013
VIA EXPRESS DELIVERY
Mr. Jamie A. Dajer, Owner
La Yuca, Cruce de Quinigua
Villa Gonzalez, Santiago
Reference No. 396438
Dear Mr. Dajer:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at La Yuca, Cruce de Quinigua, Villa Gonzalez, Santiago, Republica Dominicana on December 19-20, 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)) and the current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food regulation (Title 21, Code of Federal Regulations, Part 110, (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 received your responses to the FDA-483 on January 9, and April 26, 2013; you informed us about intended changes and that you have addressed some of the deviations, such as registering your new facility and replacing your walls and floors. However, you still have not verified corrections to the significant deviations outlined in this letter.
As a manufacturer of acidified food products intended for export into 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. 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.
Your significant violations are as follows:
1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container as required by 21 CFR 108.25(c)(2). Specifically, you have not filed your scheduled process for acidifying Aloe Vera gel and (b)(4).
2. Your firm failed 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). Specifically, you do not have a person at your processing facility involved with the daily production of Aloe Vera gel who has attended Better Processing Control School for the manufacture of acidified foods. You responded that you intend to obtain the required training for an employee, but have not yet done so.
3. Your firm failed to maintain processing records showing adherence to the scheduled processes, including records of pH measurement intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically, you are not maintaining records with actual values for the thermal processing of Aloe Vera gel manufactured and exported to the United States. In addition, you do not check the pH of your Aloe Vera gel after formulation and before thermal processing. In practice, you only check the pH after thermal processing when you adjust the pH if needed by adding more powdered citric acid.
Good Manufacturing Practices
1. Your firm failed to take effective measures to exclude pests from the processing areas as required by 21 CFR 110.35(c). Specifically, during the processing of Aloe Vera gel, the FDA investigator observed more than 100 flying insects landing on aloe leaves, food contact surfaces, and employees. In addition, crawling insects were observed on an empty drink bottle in the aloe leaf processing area. Further, your firm did not have adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, you have gaps greater than 2 cm around the window for raw Aloe Vera entering the process area by conveyor; pipes carrying water and electrical cables entering through the walls of the processing area; and along the frames of doors entering the processing area.
2. Your firm failed to construct 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, faucets connected to hoses lying in pooled water in the processing area were not protected against backflow.
3. Your firm failed to use utensils that allow for proper cleaning and maintenance as required by 21 CFR 110.40 (a). Specifically, utensils used for moving aloe leaves through wash tanks, plastic totes used for moving aloe leaves to cutting tables, and knife handles used for cleaning aloe are not constructed of materials that are easy to clean and sanitize.
4. Your firm failed to adequately maintain instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms as required by 21 CFR 110.40(f). Specifically, thermocouples used for measuring the temperature of the batch pasteurizer and scales used for measuring acidifying chemicals were not calibrated.
5. Your firm failed to use water of adequate sanitary quality to wash and rinse food as required by 21 CFR 110.80(a)(1). Specifically, the chlorinated water used for washing organic material from aloe leaves during processing is not maintained with measurable residual chlorine levels.
6. Your firm failed to inspect containers of raw materials upon receipt to ensure that their condition does not contribute to the contamination or deterioration of food as required by 21 CFR 110.80(a)(1). Specifically, containers used for delivering cut aloe leaves to the processing facility were dirty with accumulated organic material and not cleaned before re-use.
7. Your firm failed to have effective hand sanitizing preparation, provide hand washing and hand sanitizing facilities at each location in the plant where needed, provide hand-washing facilities and post readily understandable signs directing employees to wash and sanitize hands as appropriate as required by 21 CFR 110.37(e). Specifically, hand sinks in the employee toilets area and the main processing area were not equipped with hand sanitizers. Hand sinks dedicated for employee hand washing were not located in areas where employees entered the processing facility. Faucets used on hand sinks in the employee toilet area and the main processing area were only plumbed with water of ambient temperature and no signs were posted at hand sinks in the employee toilet area and the main processing area instructing employees to wash hands prior to processing activities.
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 good manufacturing practices 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 #396438 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