FDA 483 - Nypro FinPack - March 21, 2014

An FDA inspection of Nypro, A Jabil Company in Clinton, MA, resulted in a Form 483 with three observations. The firm was cited for not being ready for commercial production due to inadequate process validation for an assembly system and insufficient performance qualification for cleanroom environments. Additionally, the company failed to adequately investigate deviations related to cleanroom air change rates, indicating deficiencies in their corrective and preventive action procedures.