WARNING LETTER
Panther James LLC
MARCS-CMS 610082 —
March 05, 2021
Delivery Method:
VIA UPS
Reference #:
FY21-HAFE6-WL-01
Product:
Food & Beverages
Recipient:
Recipient Name
Caitlin G. James
Recipient Title
CEO
Panther James LLC
2070 West 11 Mile Road
Berkley
,
MI
48072
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
FY21-HAFE6-WL-01
March 5, 2021
Jennifer E. James, COO
Jessica M. James, Chief Business Development Officer
Julie James, Chief Marketing Officer
Dear Mss. James:
The U.S. Food and Drug Administration (FDA) inspected your juice manufacturing facility located at 2070 W. 11 Mile Road, Berkley, MI, from October 15, 2020, to November 2, 2020. 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 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 raw untreated juice you manufacture is adulterated in that the juice has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
You produce raw untreated juice at your Berkley manufacturing facility which you sell onsite and at your retail establishments located in Royal Oak, Detroit, Plymouth, and Bloomfield Hills. In addition, you manufacture processed juice at your Berkley facility which you sell to other business entities as well as through your retail establishments and onsite. The juice HACCP regulation contains requirements applicable to the production of juice products (21 CFR 120.3(j)(1)), but does not apply to the operation of a retail establishment (21 CFR 120.3(j)(2)(ii)). Therefore, if your Berkley facility qualifies as a retail establishment under the juice HACCP regulation, the regulation would not apply to the facility. However, as discussed further below, it is likely that part 117 would apply to the facility in such a circumstance.
A “retail establishment” is defined by the juice HACCP regulation 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)). In short, a retail establishment (1) provides juice directly to consumers and (2) does not sell juice to other business entities. Your Berkley facility sells juice to other business entities. Therefore, it is not considered a retail establishment, and the juice HACCP regulation applies to all of the juice produced at that location. Also, note that as reflected in the guidance you reference in your May 19, 2020 response (i.e., Answer 19 of Guidance for Industry: Questions and Answers on juice HACCP Regulation), juice is only considered to be provided directly to consumers if it is provided to consumers at the same location where it is produced. Accordingly, if you no longer provide juice to consumers at your Berkley facility, then it is not considered a retail establishment for this additional reason.
You may find the Act, FDA’s juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links on FDA’s home page at www.fda.gov.
The significant violations observed during the inspection are as follows:
You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply 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 a HACCP plan for your unprocessed Apple Lemon Ginger, Beet #1, Beet#2, Beet #3, Carrot Apple Celery Lemon, Carrot Orange Beet, Celery Lemon, Green #1, Green #2, Green #3, Green #4, Pear Cayenne Pepper, Watermelon, Pineapple Ginger, Apple Thieves, Blue Recovery, Coconut Shake, Daily Special, 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 to the pertinent microorganism in these juices prior to distribution. As stated above, all of the juice produced at your Berkley manufacturing facility is subject to the juice HACCP regulation because the facility is not considered a “retail establishment” under the regulation.
We reviewed your firm’s written responses dated April 6, 2020, and May 19, 2020, received after our previous inspection conducted from February 12, 2020, to March 9, 2020. We also reviewed your most recent response dated November 24, 2020. Your responses do not adequately address the inspectional observations concerning the manufacture of untreated juices without a HACCP plan and the required 5-log reduction of the pertinent microorganism. In your responses, you provided documentation regarding your firm’s plans
(b)(4)
. Based on the documentation you provided, we have determined that the business structure you describe
(b)(4)
operations at the Berkley facility for purposes of the juice HACCP regulation and, therefore, your Berkley location would
(b)(4)
to the juice HACCP regulation. Specifically, there are many shared operations between the two firms, including but not limited to:
• Shared procurement of fruits/vegetables and components such as packaging and labels
• Shared refrigeration/storage space for raw materials and components
• Shared kitchen, office and retail space
• Shared production employees
• Shared production equipment, utensils and delivery vehicles
• Same brand name for all raw/retail and HPP/wholesale products: “DROUGHT”
• Common ownership
Further, note that if
(b)(4)
at your Berkley location that produces juice only for sale onsite and at your retail locations and to which the juice HACCP regulation does not apply, such an operation would likely be subject to the preventive control requirements in 21 CFR Part 117,
1
which generally applies to facilities required to register. The exemption from preventive controls for activities subject to the juice HACCP regulation would not apply (21 CFR 117.5(c)). Additionally, such an establishment would not fall within either the retail food establishment or restaurant exemptions from the requirement to register (21 CFR 1.226). Specifically, a facility (e.g., a central kitchen) that makes juice for sale at other locations (e.g., retail locations), even if those locations are owned by the same firm, only qualifies as a retail food establishment for purposes of the registration requirement if the annual monetary value of sales of food products from that establishment directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. Sales made at separate locations, even if those locations are under the same ownership, are not sales “from that establishment” and so are not considered retail sales for purposes of this calculation (see definition of “retail food establishment,” 21 CFR 1.227). In addition, such a facility is not exempt from registration as a “restaurant” because restaurants do not include central kitchens (see definition of “restaurant,” 21 CRF 1.227). Therefore, unless another exemption applies, such a facility would be subject to the preventive controls requirements in part 117 and would be required, among other things, to have a food safety plan and to control the microbial hazards in the juice.
In light of some confusion reflected in your responses, we point out that the definition of “retail establishment” in the juice HACCP regulation (21 CFR 120.3(l)) is not identical to the definition of “retail food establishment” in the registration regulation (21 CFR 1.227). As illustrated in Answer 19 of the guidance you reference, a manufacturing facility that makes sales to consumers at the manufacturing location and also through retail stores in the same business can be a “retail establishment” under Part 120 and therefore not subject to the juice HACCP regulation. In contrast, such a facility would not be considered a “retail food establishment” exempt from the requirement to register unless its primary function is to sell food directly to consumers (i.e., sales to consumers at the manufacturing facility are greater than sales made at the separate retail locations). Viewing the regulatory scheme as a whole, an operation that manufactures juice that it sells at other locations is either subject to the juice HACCP regulation or the similar requirements for preventive controls in 21 CFR 117 unless an exemption applies.
Your firm also submitted an attestation for a Qualified Facility exemption under 21 CFR 117 on or about November 14, 2019. The agency has determined that your firm’s gross annual sales exceed the threshold for a Qualified Facility under 21 CFR 117.3.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days from your receipt of this letter, of specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent to, Kathryn Cutajar, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact CO Crivellone at
(312) 596-4157
or via email Lauren.Crivellone@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food
Operations-East 6
_________________________
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Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Content current as of:
03/23/2021
Regulated Product(s)
Food & Beverages