FDA EIR - Nypro FinPack - March 21, 2014

An FDA Pre-Approval inspection of Nypro, A Jabil Company, in Clinton, MA, occurred from March 5-21, 2014. The inspection focused on the firm's contract manufacturing of a combination drug and device product, adhering to regulatory frameworks including 21 CFR Part 4 (Combination Products), 21 CFR 820 (Medical Devices), and applicable sections of 21 CFR 211 (Drugs). The inspection revealed three main issues documented on a Form FDA 483. Firstly, the company had not initiated Process Performance Qualification (PPQ) for its commercial-scale assembly and release testing system, signifying inadequate process validation. Secondly, the performance qualification for the ISO-8 cleanroom was incomplete, and a materials transfer room lacked adequate testing to confirm its ISO-8 classification. Lastly, the firm's corrective and preventive action procedures were found to be insufficient due to an inadequate investigation into cleanroom air change rates that failed to meet acceptance criteria during Operational Qualification. Nypro management agreed to correct these observations and committed to submitting a formal written response to the FDA within 15 business days. Required actions also included establishing a justified environmental monitoring program, re-evaluating cleaning agents, and improving documentation of qualification failures. The firm acknowledged these issues needed resolution before initiating commercial PPQ batches.