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"Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release." — FDA Warning Letter, Guangdong Renhe Guozhuang Biotechnology Co., Ltd., 2025 A corrective and preventive action system that exists on paper but doesn't close the loop on real problems is a liability

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10.1091/mbc.e16-08-0624 Mol