Case Study: Foreign Mfg Plant CAPA System

A medium size manufacturer of disposable therapeutic products needed to determine the compliance status of the CAPA system at one of their foreign manufacturing plants as part of an overall review of the plant's quality system in preparation for an expected FDA audit.

AlvaMed reviewed their CAPA system and determined that several improvements were necessary to bring the system into compliance. Detailed recommendations for specific changes were made to plant management.

The recommended changes were implemented shortly after the AlvaMed report was submitted.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control