January 2010The US Food and Drug Administration has conducted a 5 days full GMP audit at Zach System S.p.A. plant in Lonigo from January 18th through January 22nd.
The audit has covered Quality systems, Equipment and Facilities, Materials, production, Packaging and Labeling and Laboratory controls, and was focused to the two main products for United States, Gabapentine and Sulindac.
The auditor concluded the audit without issuing any 483; this is the 7th FDA audit in a row without observation over the last 18 years of the plant History, an outstanding record in the pharmaceutical industry that has been achieved thanks to the hard work and commitment of our colleagues in Lonigo.
Congratulations for the achievement.