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.

 

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments