FDA 483 - Longbow First Aid Products Manufactory - April 20, 2018

Longbow First Aid Products Manufactory, a drug product manufacturer in Guicheng, China, was cited for numerous significant deficiencies during an FDA inspection. Key issues include a lack of validated sterilization processes and sterility testing for sterile OTC products, inadequate component identity testing, and poor facility management regarding storage space and equipment cleaning. The firm also failed to maintain proper batch production records, implement a stability program, and follow instrument calibration procedures, indicating a broad breakdown in quality control and GMP compliance.