FDA successfully completed a 5-Day inspection of PROCAPS sites in Barranquilla with no Form 483 issued
PROCAPS S.A. is pleased to announce that the US Food and Drug Administration (FDA) completed an inspection of our quality system, manufacturing facilities, and labs thorough a 1-week GMP audit in our sites in Barranquilla, Colombia.
The inspection confirmed the sites to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP), and no Form 483 was issued. The US FDA authorities inspected the facilities from September 28th to October the 2nd, 2015 having originally inspected and approved the sites in 2009, and 2012. Another significant achievement that makes us very proud.