Category: Warning Letters

The Warning Letters category analyzes FDA enforcement actions that reveal critical GMP deficiencies observed during inspections. These letters cite issues such as data integrity, aseptic practices, quality systems, cleaning validation, and product testing, offering lessons with global relevance.

Articles place findings in context, showing how enforcement priorities evolve and what they mean for compliance strategies worldwide. While issued by the FDA, the insights are applicable across markets where regulators align with similar GMP standards.

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FDA Warning Letter Analysis: Diamond Chemical Co., Inc.

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...
FDA Issues Warning Letter to LS Promotions INC. for cGMP Violations

FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...
FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation,...
FDA Issues Warning Letter Due to cGMP Violations

FDA Issues Warning Letter Due to cGMP Violations

FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....

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