FDA 483 - Alto ICP, LLC

Alto ICP, LLC, a drug substance manufacturer in Pekin, IL, was cited for significant deficiencies in its manufacturing processes, quality control, and data integrity during an FDA inspection. Observations included inadequate batch record controls, incomplete electronic record assurance, an insufficient stability program for its Ethyl Alcohol 190 ULTRA products, and a lacking supplier qualification program for contract laboratories. These issues indicate a lack of robust quality systems for API and excipient production.