Boiron Freres SAS 4/18/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD |
VIA OVERNIGHT DELIVERY
Mr. Alain Boiron, President and Owner
Boiron Freres SAS
26958 Valence Cedex 9, France
Reference No.: 285279
Dear Mr. Boiron:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility located at Parc d’Activites de 45 eme Parallele, 1 rue Brillat-Savarin, Chateauneuf-Sur-Isere, France on December 15-16, 2011. 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 & 110). 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 100% frozen fruit and vegetable purees, which are subject to the requirements of 21 CFR Part 120, are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they 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
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. We acknowledge your firm’s January 6, 2012 response to the FDA-483, which includes corrective actions you have taken in response to these deviations. However, your response does not fully address the deviations found. After review of the inspection findings and your firm’s response, your firm’s significant deviations remain as follows:
1. Your HACCP plans do not include control measures that will consistently produce a 5-log reduction of the pertinent microorganisms as required by 21 CFR 120.24(a) through measures applied directly to the juice as required by 21 CFR 120.24(b). Specifically your HACCP plans for the following products fail to include an adequate process control measure to consistently produce a 5-log reduction of the pertinent organism: green apple puree (Puree Pomme Verte), cucumber puree (Puree Concombre), kiwi puree (Puree Kiwi), banana puree (Puree Banane), lemon puree (Puree Citron Jeure), lime puree (Puree Citron Verte), kalamansi puree (Puree Kalamansi), citrus concentrate (Concentre Citron), mandarin orange concentrate (Concentrate Mandarine), and orange concentrate (Concentrate Orange).
Your firm’s response identified the following microbial critical control points (CCPs) as part of your revised HACCP plans for each of the products listed (b)(4) is an inadequate process control measure as it is a surface treatment applied to intact fruit and not applied directly to the juice itself; therefore, (b)(4) step does not contribute to the 5-log reduction as required by 21 CFR 120.24(a). (b)(4) only controls bacterial growth and therefore this is also not a pathogen reduction measure. Lastly, your response indicates that various pathogens do not grow during the (b)(4) step and that there was (b)(4). Temporarily preventing the growth of various pathogens is not an adequate pathogen reduction measure and therefore, freezing b`(4) is not an acceptable CCP for control of these pathogens. In addition, (b)(4) and therefore does not meet the 5-log reduction as required in 21 CFR 120.24(a).
Your firm’s supplemental hazard analysis indicates that you analyze each batch of product for pathogens. However, random end product testing/analysis of each batch does not achieve an equivalent level of safety and can not be used as a substitute for implementation of an adequate HACCP based program of control that ensure continuous and repeatable elimination of the pathogens from each batch.
2. You did not validate that your HACCP plan is adequate to control food hazards that are reasonably likely to occur as required by 21 CFR 120.11(b). Specifically, for the products you pasteurize or blanch, you have not validated your pasteurization or blanching time and temperature parameters to demonstrate they are sufficient to inactivate the pertinent microorganisms of concern for your fruit and vegetable puree products including, but not limited to, strawberry puree (Puree Fraise), raspberry puree (Puree Framboise), and black currant puree (Puree Cassis).
We acknowledge that your response indicates that you have obtained a quote from an outside party to conduct validation studies of your pasteurization and blanching thermal processing units. However, until these validation studies are completed, we cannot be assured that your pasteurization and blanching processes are capable of achieving a 5-log pathogen reduction.
In addition, you do not verify that you are maintaining your specified temperatures for the times specified in your HACCP plan, in that your large high temperature short time (HTST) tube-in-tube pasteurizer does not have a temperature indicating device at the end of the hold tube, and you do not measure the length of time that products heated in the blanche pasteurizers are maintained at your specified temperatures. If your firm’s processes are found to capable of achieving a 5-log pathogen reduction based on the validation studies, you are required to adequately monitor the critical limits identified and implement corrective actions when deviations from those critical limits occur.
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 further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. 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 or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported 100% frozen fruit and vegetable purees 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 which 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 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 send your reply to the U. S. Food and Drug Administration, Attention: Robyn R. Jones, 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. Jones at (240) 402-2575 or via email at firstname.lastname@example.org
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition