Protica, Inc. – FDA Warning Letter, Oct 6, 2011

The FDA inspected Protica, Inc. from September 29 to October 6, 2011, finding significant violations of Acidified Foods Current Good Manufacturing Practice regulations (21 CFR Parts 108 and 114) and Dietary Supplement CGMP regulations (21 CFR Part 111).

For acidified foods, Protica failed to provide scheduled process information for approximately (b)(4) products, except for one representative product in four categories, and lacked a scheduled process for citric-based protein liquid drinks (21 CFR 108.25(c)(3)(ii)). The firm also failed to process foods in conformity with filed scheduled processes, with observed fill temperatures deviating from the critical factor of (b)(4) F for numerous products (21 CFR 108.25(c)(3)(i) and 21 CFR 114.80(a)(1)). Additionally, Protica did not file processes for various container sizes (1oz., 2oz., 4oz., 8oz., 10oz., 16oz., 20oz.), relying on representative sizes, which is unacceptable without scientific study (21 CFR 108.25(c)(2)).

For dietary supplements, specifically Rapid Refuel 20oz., lot (b)(4), Protica failed to verify finished batch specifications for identity, purity,