FDA 483 - Bactolac Pharmaceutical, Inc. - June 25, 2015

An FDA inspection of Bactolac Pharmaceutical, Inc., a dietary supplement contract manufacturer in Hauppauge, NY, revealed two significant observations. The firm failed to adequately investigate a product complaint involving metal fragments and did not extend the investigation to other potentially affected batches. Additionally, the company lacked proper quality control review and approval for in-house standard reference materials used in laboratory testing, specifically for botanical identity specifications.