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  5. Panther James LLC. - 565987 - 02/01/2019
  1. Warning Letters

WARNING LETTER

Panther James LLC. MARCS-CMS 565987 —

Recipient:
Recipient Name
Caitlin G. James
Recipient Title
CEO
Panther James LLC.
Panther James LLC.

2070 West 11 Mile Road
Berkley, MI 48072
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

Dear Mss. James,

The U.S. Food and Drug Administration (FDA) inspected your juice manufacturing facility located at 2070 W. 11 Mile Rd., Berkley, MI from August 15, 2018 to August 31, 2018.  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 120).  In accordance with 21 CFR Part 120, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR 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, the juice you manufacture is adulterated in that the juice has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Our inspection determined that you sell raw juice directly to consumers and sell or distribute high pressure processed juice to other business entities. Accordingly, you do not meet the definition of a “retail establishment” and therefore you are not exempt from the Juice HACCP regulation. A retail establishment is defined as “an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers.” (21 CFR 120.3(l)).

You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links on FDA’s home page at www.fda.gov.

The significant violation observed during the inspection is as follows:

  • You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur in accordance with 21 CFR 120.8(a).  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).  However, you do not have HACCP plan for your Apple Lemon Ginger, Beet #1, Beet #2, Beet #3, Carrot #1, Green #1, Green #2, Green #3, Green #4, Carrot Orange Beet, Pear Cayenne, Apple Thieves, Watermelon, Pineapple Ginger, Ginger Shot, Turmeric Shot, and Immunity Potion juices that you distribute to your retail stores.  In addition, you do not apply a 5-log reduction of the pertinent microorganism in these juices prior to distribution.  As stated above, your firm does not meet the definition of a “retail establishment” because you also distribute juice wholesale.

We acknowledge your written response received by FDA on September 24, 2018. We have reviewed your written response and concluded that it does not adequately address the inspectional observations concerning the lack of HACCP plans and the lack of 5- log treatment of the pertinent microorganism.

Additionally, in response to the FDA 483, you provided a process authority letter (Appendix 2) to support your high pressure processing parameters and critical limit.  Upon review, we note that many of the literature citations listed in the letter do not appear to be directly applicable to your process.  For example, many of these studies were either conducted at higher temperatures (e.g., 20° C, 10° C) or for longer time (e.g., 5 min, 10 min).  Temperature and time can affect HPP efficacy.  In addition, when juice processors rely on a published study as validation for their processing parameters, the product composition and critical operational parameters used in the study should closely match the processor’s actual product and process.  It is unclear how the products in the studies were compared with your products.  We recommend you work with your process authority to ensure your HPP process is validated for each of your products and their specific characteristics, compositions, and pertinent microorganisms.

The violation cited in this letter is not intended to be an all-inclusive statement of violations that exist at your facility.  You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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 FD&C 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 domestic facility, FDA will assess and collect fees for reinspection-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 FD&C Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

You should respond to this letter in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future.  Your response should include any documentation necessary that would assist us in evaluating your corrections.  If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Your firm’s response should be sent to, Dr. Byron Ho, DVM, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Dr. Byron Ho at (313) 393-8262 or via email byron.ho@fda.hhs.gov.

 

Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Food Operations
Division East 6

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