The Food and Drug Administration cited a Michigan company known for its raw and cold-pressed juices for violating federal food safety law in a warning letter recently made available to the public.

The Feb. 1 letter references an inspection from Aug. 15-31, 2018 and says juices at the production operation Panther James LLC in Berkley, MI, are adulterated because the facility doesn’t have a plan for and documentation of proper Hazard Analysis and Critical Control Point procedures. Such procedures are, in part, designed to prevent the growth of microorganisms that can cause foodborne illnesses.

Although the warning letter was addressed to the Panther James LLC business entity, it was sent to the attention of sisters Caitlin G. James, CEO; Jennifer E. James, COO; Jessica M. James, Chief Business Development Officer; and Julie James, Chief Marketing Officer. 

The women’s company produces Drought brand juices, which are sold across the Midwest, according to their company’s website, in retail stores, wholesale quantities, and direct to consumers via online sales. 

The FDA warning acknowledges receipt of a letter from the James sisters in September 2018, but says problems at the juice production plant were not resolved.

“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,” according to the FDA warning letter.

The juice products that are adulterated and therefore ineligible for sale because of the HACCP violation include “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,” the FDA inspectors reported.

FDA officials also said the processing parameters and critical limits used by the juice producers are not designed for their products.

“Upon review, we note that many of the literature citations listed in (your) letter do not appear to be directly applicable to your process,” accordint to the FDA warning letter.

“… 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.”

If the juice producers do not promptly correct the violations, the FDA can pursue legal action without further notice, including, without limitation, seizure and injunction. The company owners have 15 working days from their receipt of the letter to file their response.

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