Pharmaceutical Expertise Areas of Expertise Methods Audits & Approvals History
 
line Atlantic Analytical Laboratory Home line Sample Submission line Contact Atlantic Analytical Laboratory
 

Audits & Approvals— FDA

 
     
     
   
  Atlantic Analytical has progressed in applying its gas supplier industrial guidelines to the pharmaceutical industry. In January 2001, a 483 was issued citing “VAI” (Voluntary Action Indicated). The most recent audit verified that all voluntary action cited back in 2001 had been completed in a timely manner, and in June 2004, “no 483 was issued”.

We welcome pharmaceutical company audits so that we can continually strengthen our position in FDA compliance testing. Please refer to the link below for a “confidential information blacked out copy” of its June 2004 inspection report, with some minor VAI which has been addressed.

 
     
 
FDA Inspection June 2004