New England District Office (NWE-DO) One Montvale Avenue, 4th floor Stoneham, MA 02180 Phone 781.587.7500
CMS # 507525
UNITED PARCEL SERVICE
November 21, 2016
Stay Fresh Foods, LLC
65 Chamberlain Highway
Meriden, CT 06451-2829
Dear Ms. Lawless:
The Food and Drug Administration (FDA) conducted an inspection of your firm’s high pressure processing operations at 65 Chamberlain Highway, Meriden, CT, from August 2 through 12, 2016. This inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation - Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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 United States Code (U.S.C.) 342(a)(4)]. Therefore, the 100% juices processed for your customers by your firm 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 on the FDA’s Internet home page at www.fda.gov.
We received your responses dated August 25, 2016 and September 20, 2016 which responded to the Form FDA-483, List of Inspectional Observations issued to your firm on August 12, 2016. Our comments regarding the adequacy of your responses are included below.
Your significant violation is as follows:
1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of the pertinent microorganism, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). Specifically, your HACCP plan for low acid juices, entitled “Low Acid Juice HACCP”, does not include control measures to achieve a minimum 5-log reduction of Clostridium botulinum, the pertinent microorganism for the refrigerated 100% low acid juice products you process. This is based on our finding that your firm has not validated, as required by 21 CFR 120.11(b), that your processes (refrigeration and the high pressure processing (HPP)) achieve the requisite 5-log reduction to control Clostridium botulinum. FDA has information to support that HPP coupled with refrigeration are not validated processes that can reduce the spores of Clostridium botulinum in low-acid juices. In fact, non-proteolytic spores of Clostridium botulinum can grow and produce toxin in low acid juice even under refrigeration temperatures.
For further information related to microbiological concerns in low acid juice products, please reference this FDA guidance document:
Your firm’s August 25, 2016 response to the FDA-483, in addition to subsequent e-mail communication and phone discussions with New England District, indicated that you will require your customers to sign a “quality questionnaire” that confirms they have a HACCP plan that accounts for any appropriate hazards and that their plan is validated annually. You also state that your firm has no responsibility for formulation or the production process of your customers. Your responses are inadequate because your firm is considered a juice processing facility subject to the requirements in 21 CFR Part 120, which includes having control measures in place to achieve a consistent 5-log reduction of the pertinent microorganism.
In addition to the issues identified above for low acid juices, you have still not provided scientific data or evidence that the current critical limits being used by your firm for HPP are sufficient to control the hazards associated with acidic juices you process at your facility.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and applicable federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, 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 domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491 or at email@example.com.