April 5, 2011
LAKEWOOD, N.J.Soluble Products Co. LP received a warning letter from FDA in late March related to violations of 21 CFR Part 111, related to cGMPs (current good manufacturing practices) for dietary supplements. FDA inspected the manufacturing facility in early August 2010 and noted several serious" violations of the cGMPs, which cause the cited dietary supplementsseveral types of Revival Soy Pro Water Mixto be adulterated.
FDA first noted the company did not establish component identity specifications for each component used in the manufacture of the Revival products. Further, the Master Manufacturing Records (MMR) for one type of Revival product (Revival Brand Unsweetened Chocolate) did not include identity and weight of each ingredient to be declared on the label, a statement of expected yield, a description of packaging and representative label, nor specifications of control points in the manufacturing process. The same product also lacked verification that finished product specs were met via finished product testing.
The agency also cited concerns about testing of components that are not dietary ingredients, as the company relies on a certificate of analysis (C of A) for such components; further, the companies supplying those ingredients are not qualified, or no documentation of how the suppliers are qualified is maintained. Finally, FDA stated while the company retains reserve samples for two years from date of manufacture, the law requires retention of reserve samples for one year past shelf life date or two years from date of distribution of the final batch of product associated with that sample.
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