FDA 483 - Porton Biopharma Limited - March 21, 2021

An FDA inspection of Porton Biopharma Limited, a drug substance and sterile drug product manufacturer in Salisbury, United Kingdom, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate customer complaints and out-of-specification results, did not follow procedures to prevent microbiological contamination, and had issues with quality unit responsibilities and documentation of nonconformance events. These observations indicate a serious lack of adherence to good manufacturing practices.