The U.S. FDA has warned Chinese manufacturer Foshan Flying Medical Products for testing, training and validation issues at its Guangdong, China plant.
The inspection took place from February 20-23, 2017. According to the FDA letter, dated August 1, the facility:
• lacks an adequate quality control unit
• released finished drug products without adequate acceptance testing
• failed to perform sterility testing
• lacks an ongoing program for monitoring process control
• failed to prepare batch production and control records with complete information
• was unable to provide any CGMP-related training documentation
Based upon the nature of the violations we identified, the FDA strongly recommended the company hire a consultant, qualified as set forth in 21 CFR 211.34, to assist in meeting CGMP requirements.