FDA 483 - Alto ICP, LLC

Alto ICP, LLC in Pekin, IL, a manufacturer of active pharmaceutical ingredients and excipients, received a Form 483 with four observations. The inspection revealed significant deficiencies in batch record control, electronic record integrity, the stability program for its Ethyl Alcohol 190 ULTRA products, and the supplier qualification program for contract laboratories. These issues indicate a lack of adequate controls over manufacturing processes, data management, product stability, and outsourced testing.