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cGMP Compliance Posture

Following the new approach taken by FDA in October of 1994 with the more rigorous application of cGMPs to offshore API producers FCC invested significantly in GMP compliance. Facilities were upgraded and a systems approach across the whole spectrum of the business was taken to bring GMPs up to the required standard.

A variety of US based consultants were used alongside local management to implement the required changes and since then a management structure has been implemented to ensure ongoing control over GMP. The effectiveness of this has been indicated by numerous successful customer inspections, including those by major international pharmaceutical companies. In addition, no Form 483 was issued nor were any adverse findings noted following the last four FDA inspections that took place in July 1996, November 1999, September 2002 and October 2006.

 


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