A division of Dosage Form Solutions
Encap facility classified as acceptable after recent US FDA inspection
Encap Drug Delivery was inspected by the US FDA from 13-17th Sep 2010. The inspection was a full six system GMP inspection covering the Quality System, Facilities and Equipment, Materials Management, Production, Packaging and Labelling, and Laboratories.
We are pleased to report that we have now received official notification from the International Compliance Branch, classifying our facility as acceptable. Following on from our successful FDA Pre-Approval Inspection (PAI) in 2008 this is very good news for Encap Drug Delivery and our customers as we plan for further NDA and ANDA submissions in the coming months and years.
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