Caitlin G. James
CEO
Panther James LLC
2070 West 11 Mile Road
Berkley , MI 48072
United StatesFEI 3012327310Issued Mar 5, 2021Division of Human and Animal Food Operations East VI
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012327310.
Violations5
Issue DateMar 5, 2021
Product TypeFood & Beverages
StatusClosed
Closeout LetterNov 18, 2022
Letter Details
Firm
Panther James LLC
Location
Caitlin G. James
CEO
Panther James LLC
2070 West 11 Mile Road
Berkley , MI 48072
United States
FEI Number
3012327310
Country
United States
Issue Date
March 05, 2021
Issuing Office
Division of Human and Animal Food Operations East VI
Product Type
Food & Beverages
Status
Closed
Closeout Letter
November 18, 2022
Summary
Panther James LLC, a juice manufacturer in Berkley, Michigan, was cited for serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 120) during an FDA inspection conducted from October 15 to November 2, 2020. The company failed to have and implement a compliant HACCP plan for its raw untreated juice products, which rendered them adulterated and potentially injurious to health as they were prepared, packed, or held under insanitary conditions. Panther James manufactured and distributed both raw untreated juice sold onsite and at multiple retail locations (Royal Oak, Detroit, Plymouth, and Bloomfield Hills), as well as processed juice sold to other business entities, making the scope of the violations significant.
Panther James LLC FDA Warning Letter, March 5, 2021