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During the inspection of a manufacturer of PET drug products in June 2025, the FDA identified numerous GMP deficiencies and violations of 21 CFR Part 212. PET drug products (Positron Emission Tomography Drugs) are short-lived radiopharmaceutical injection preparations used in nuclear medicine diagnostics. The deficiencies have now been detailed in a Warning Letter. Read more here.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an EU-based OTC drug manufacturer (Czech Republic) after reviewing documents submitted after a request for records and other information. Key findings include missing incoming material identity testing, no stability program despite labeled expiry dates, inadequate process validation, insufficient method validation and microbiological control, and incomplete laboratory documentation.

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Two FDA Warning Letters issued in April illustrate how quickly FDA confidence erodes when investigations stop at retesting, "probable cause" statements, or training-only fixes, without an evidence-based root cause, appropriate scope expansion, and demonstrable CAPA effectiveness.

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FDA is piloting one-day inspectional assessments to make oversight more targeted and efficient. The initiative introduces shorter, focused screening visits alongside standard inspections.

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The Chinese National Medical Products Administration (NMPA) – through the Centre for Drug Evaluation and Inspection (CDEI) – has released a draft guidance for public comment on the inspection of data integrity in pharmaceutical quality control laboratories. The document highlights inspector expectations for data reliability (ALCOA++) in pharmaceutical quality control laboratories, covering governance, lifecycle data management, risk-based controls, and typical deficiencies in paper, computerized and hybrid environments.

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A Warning Letter issued by the FDA in February once again highlights the inadequate microbiological testing of non-sterile medical devices. In some cases, devices were approved without any testing at all.

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In both, the EU and the US, it is illegal to place a medicinal product on the market without approval. This raises the question: What do you need to know from a GMP perspective about medicinal product authorisations in the EU and the US?

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The use of reference substances is a key component of pharmaceutical analysis and quality assurance. Reference substances (or reference standards) play a crucial role in ensuring the safety, harmlessness and efficacy of medicinal products. Find out more on how reference substances are used in the pharmaceutical industry.

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US FDA has published a Warning Letter highlighting weaknesses that can occur in any GMP process. In this Letter OOS investigations and changes in electronic systems were not adequately addressed in the CAPA system.

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The FDA has issued a new Warning Letter to an OTC drug manufacturer in Palm Bay, Florida. The agency cites significant CGMP deficiencies, with a strong emphasis on laboratory control and analytical oversight, including missing finished-product testing prior to batch release, weaknesses in incoming-material testing and supplier/COA qualification, an inadequate stability program, and inadequate QU oversight.

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