cGMPs / Over-the-Counter

FDA Warns China’s Foshan Flying Medical

Aug 17, 2017

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.