FDA 483 - Silgan Unicep Packaging LLC - May 25, 2018

An FDA inspection of Unicep Packaging, LLC in Sandpoint, ID, a contract manufacturer of OTC drugs and veterinary medicines, revealed significant deficiencies. The firm failed to follow procedures for preventing objectionable microorganisms in its purified water system, including not performing investigations or microbial identifications when action levels were exceeded. Additionally, the company did not retain samples for active ingredients used in OTC homeopathic drugs.