Checklist for FDA Regulatory Compliance in Contract Manufacturing: QTA, Controls, and Inspection-Ready Operations FDA Compliance Checklist for Contract Manufacturers: What Sponsors and CMOs Must Get Right Scope and Applicability: Who Owns What in Sponsor–CMO Arrangements In U.S. drug manufacturing, contracting work to a Contract Manufacturing Organization (CMO/CDMO) never shifts responsibility for cGMP compliance away from the application holder. The sponsor (NDA/ANDA/BLA holder) and the CMO share operational tasks, but FDA views the sponsor as ultimately accountable for product identity, strength, quality, purity, and potency. This means your compliance checklist starts with a precise definition of scope across the product lifecycle:…