Inspections, Compliance, Enforcement, and Criminal Investigations
Fresh Directions Dominicana 11/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20740
NOV 25, 2013
VIA EXPRESS DELIVERY
Mr. Manuel Castillo Pimentel, President
Fresh Directions Dominicana
175 SW 7th Street, Suite 1505
Miami, FL 33130
Reference No.: 414653
Dear Mr. Manuel Castillo Pimentel:
The U.S. Food and Drug Administration (FDA) inspected your processing facility Fresh Directions Dominicana, located at Calle 2da, No. 5, El Mango, Quita Sueno, San Cristobal, Dominican Republic on June 20-21, 2013. During that inspection, we found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 120 and 110). At the conclusion of the inspection, the FDA investigator issued a form FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your responses sent on July 12, 2013 and September 14, 2013. Your responses included descriptions of your corrections to the sanitation deviations and the HACCP-related deviations, a HACCP manual with your process flow diagram, an English version of your HACCP plan, and descriptions of your operations. Our evaluation of the submitted documentation revealed that your firm adequately addressed the CGMP deviations; however, your response was not adequate in addressing the HACCP deviations, as further described in this letter.
In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your frozen mango pulp, which is subject to the requirements of 21 CFR Part 120, is adulterated in that it has been prepared packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant deviation is as follows:
You must include in your juice HACCP plan for frozen mango pulp (b)(4) that will consistently produce, at a (b)(4), for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, for the pertinent microorganism (i.e., most resistant microorganism of public health significance likely to occur in the juice), to comply with 21 CFR 120.24. However, your juice HACCP plan for frozen mango pulp submitted on September 14, 2013, does not include (b)(4) that will consistently produce a (b)(4) of the pertinent microorganism as required by 21 CFR 120.24(a) through measures applied directly to the juice as required by 21 CFR 120.24(b).
Your firm’s July 12 response states that your firm has pre-requisite programs that prevent the contamination of the mango fruit as a raw material for the production of your mango pulp. For example, your response references a “(b)(4)” step using a (b)(4) ''slow the growth of pathogens." In addition, your response references the natural acidity of the product and that the finished product is vacuum-packed, sealed and kept frozen to keep the microbiological load low. However, these measures are not adequate to achieve a 5-log pathogen reduction as required by 21 CFR 120.24(a).
We note that your firm intends to implement a high pressure processing system to be installed by the end of this year, in order to meet the (b)(4) as required under 21 CFR 120.24. Please note that the implementation of this type of processing technology would require verification and validation of the HACCP system and related updates to your juice HACCP plan for frozen mango pulp.
You should respond in writing within 15 working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised juice HACCP plan for frozen mango pulp, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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 or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your frozen mango pulp under Section 801(a) of the Act (21 U.S.C. § 381(a)), including subjecting it to 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. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the juice HACCP regulation is Import Alert #20-07. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/importalert_761.html
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), the CGMP regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-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 re-inspection-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: Asha Dwarka, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Dwarka at (240) 402-5164 or via email at Asha.Dwarka@fda.hhs.gov.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition