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FDA PAI and general GMP inspection of two aseptic manufacturing plants and QC laboratory completed successfully
March 6, 2017
By: Tim Wright
Editor-in-Chief, Contract Pharma
Lyophilization Services of New England (LSNE) has completed two FDA inspections of their aseptic manufacturing facilities. These inspections were conducted in January and February of 2017. The first inspection was an FDA Pre-Approval Inspection (PAI) of their aseptic manufacturing facility located at Commerce Drive in Bedford, NH. As a result, the Commerce Drive facility has been recommended for approval to manufacture the commercial sterile drug product for U.S. distribution. This PAI, which ...
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