FDA 483 - Porton Biopharma Limited - May 21, 2021

An FDA inspection of Porton Biopharma Limited in Salisbury, UK, a manufacturer of drug substances and sterile drug products, revealed significant quality control issues. The firm failed to thoroughly investigate customer complaints regarding particulates in sterile vials and did not follow procedures to prevent microbiological contamination during aseptic filling. Additionally, the quality unit did not implement effective corrective actions for recurrent out-of-specification results, and multiple nonconformance events were not documented in a timely manner.