Case Study: Foreign Plant QSR Gap Analysis

A manufacturer of disposable vascular products wanted an independent review of the quality systems at one of their foreign manufacturing plants prior to an FDA audit.

AlvaMed reviewed the plant's entire quality system and rated each aspect of the system using an easy to understand method. AlvaMed identified various areas needing improvement and recommended specific solutions and priorities for implementing them.

The company undertook a program to implement the recommended changes. The high-priority changes were implemented quickly and intermediate and long term programs were established to address the less urgent issues. AlvaMed continued to assist the client in implementing a number of the solutions.
 

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