FDA 483 - AmbioPharm, Inc - February 09, 2023

AmbioPharm, Inc. in Beech Island, SC, a peptide-drug substance manufacturer, received a Form 483 with two significant observations. The inspection revealed issues with the QC laboratory's handling of out-of-specification results, including repeated invalidations and re-testing without adequate controls, and a lack of real-time data documentation. Additionally, the firm failed to maintain sufficient control over its water systems, leading to persistent microbial contamination and objectionable organisms in components used for drug substances.