FDA 483 - Alcami Corporation - August 23, 2016

Alcomi Corporation, a contract testing laboratory in Edison, NJ, was cited for inadequate laboratory controls during an FDA inspection. The firm failed to establish scientifically sound and appropriate test procedures, specifically by not fully adhering to USP <81> for microbial assays of antibiotics. This indicates a significant deficiency in ensuring the identity, strength, quality, and purity of drug products.