Protein Product Maker Gets FDA Warning

PHILADELPHIAProtica Inc. found itself on the receiving end of an FDA warning letter, after the agency determined the company's responses after an October 2011 FDA inspection and issuance of a 483 were inadequate in many instances. The Whitehall, Pa.-based company produces acidified protein and energy drinks, gelatin snacks and dietary supplements. It issued a written response to FDA's 483 on Oct. 12, 2011.

In its February warning letter, FDA first focused on violations of requirements of the Acidified Foods cGMP (current good manufacturing practice) regs and Emergency Permit Control, as related to registration and filing of process information. FDA inspectors had requested process and procedure information related to four products, and found no scheduled process for any citric-based protein liquid drinks. Further, the agency inspectors found deviations in the temperature used in the fill for several products. While Protica's response indicated it would request the processing letters FDA asked for, as well as those indicating an allowance for deviation related to a sliding pH/temperature scale, the letters were not provided to the agency. In addition, while the company filed process information on representative sizes for each product category, FDA stated "filing a representative size, for the same product, is not an acceptable practice unless you have determined, through a scientific study that the process results in a safe product."

The agency also called out "significant" violations of federal cGMPs for dietary supplements, which it determined resulted in the Rapid Refuel Dietary Supplement products to be adulterated. Among these were a failure to verify finished products meet product specs; that quality control (QC) personnel did not reject products that didn't meet specs, specifically for Staphylococcus Aureus levels above spec; failure to quarantine ingredient components until QC staff released them; and failure to prepare and follow master manufacturing records (MMRs) and complete batch production records (BPRs) for each formulation and batch size of dietary supplements.

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