Episciences Inc – FDA 483, Mar 11, 2022

An FDA inspection of Episciences Inc. in Boise, ID, a drug manufacturer of non-sterile topical products, revealed significant deficiencies in their quality control and manufacturing processes. Observations included inadequate finished product testing for identity, strength, and microbial contamination, as well as insufficient investigations into out-of-specification results. The firm also failed to adequately validate manufacturing processes, ensure proper sampling, verify raw material identity, and maintain adequate equipment cleaning procedures.