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Failure to have a specific plan to identify hazards earns firm a federal warning

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Panther James LLC
2070 West 11 Mile Road
Berkley, MI 

In a March 5 warning letter addressed to Jennifer James, COO, Jessica James, chief business development officer, and Julie James, chief marketing officer, FDA officials outlined problems with the operation of Panther James LLC.

The U.S. Food and Drug Administration (FDA) inspected the juice manufacturing facility in Berkley, MI, from Oct. 15, 2020, to Nov. 2, 2020. This inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation.

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 federal Food, Drug, and Cosmetic Act. Accordingly, the raw untreated juice manufactured by Panther James is adulterated in that the juice has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

The company produces raw untreated juice at its Berkley manufacturing facility, which it then sells sell onsite and at its retail establishments in Royal Oak, Detroit, Plymouth, and Bloomfield Hills. 

In addition, the company manufactures processed juice at the Berkley facility which it sells to other business entities as well as through retail establishments and onsite. 

The significant violations observed during the inspection are as follows:

Producers must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. They must include 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. 

However, Panther James does not have a HACCP plan for its 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 it distributes to retail stores. In addition, the HACCP plan does not apply a 5-log reduction to the pertinent microorganism in these juices prior to distribution. 

All of the juice produced at the Berkley manufacturing facility is subject to the juice HACCP regulation because the facility is not considered a “retail establishment” under the regulation.

Inspectors reviewed the firm’s written responses dated April 6, 2020, and May 19, 2020, received after FDA’s previous inspection conducted from Feb. 12, 2020, to March 9, 2020. Inspectors also reviewed the company’s most recent response dated Nov. 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,” the warning letter states. 

“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

“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),” the warning letter states

“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.”

To read the entire warning letter click here.

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