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Inadequate Media Fills at a Sterile Manufacturer: CGMP Case Study by FDA National Drug Expert Ileana Barreto-Petit

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

FDA National Drug Expert Ileana Barreto-Petit presents an in-depth analysis of the findings, lessons learned, and how companies can avoid similar findings in regard to a CGMP inspection case study. This case study involves a large, foreign manufacturer of injectable drug products. The product in question is a combination product.

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