FDA 483 - Ernest Jackson & Co., Ltd. - October 21, 2022

An FDA inspection of Ernest Jackson & Co., Ltd. in Crediton, UK, revealed significant deficiencies in their manufacturing operations. The firm failed to establish adequate production and process controls, particularly concerning equipment cleaning, cross-contamination prevention, and batch segregation. Additionally, the inspection found failures in investigating discrepancies and customer complaints, and a lack of proper verification for microbiology testing results.