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In July and September 2025, the Questions & Answers documents relating to centralised authorisation procedures were updated again and published on the European Medicines Agency (EMA) website.

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The comment periods for the USP chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' closed at the end of 2024. In the meantime, both chapters have been finalised and are now available for viewing. Both documents are set to become officially valid in February 2026.

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The FDA Office of Pharmaceutical Quality has published its fiscal year 2024 Report on the State of Pharmaceutical Quality, including a summary on Warning Letters, Import Alerts and Recalls.

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During an inspection, the FDA identified significant deficiencies in microbiological safety, as well as in the handling of deviations and maintenance, at a Swedish manufacturer. As the responses and measures taken by the company concerned were deemed insufficient, the FDA has now issued a Warning Letter.

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On 12 August 2025, the U.S. Food and Drug Administration (FDA) published a Warning Letter to a U.S.-based manufacturer of over-the-counter (OTC) drug products. During an inspection, the investigator observed several specific CGMP violations.

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In a Warning Letter sent to an american manufacturer in June, the FDA documents a whole list of deficiencies, ranging from a lack of testing of the components used to incorrect or faulty approvals, claims, and listings.

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During an inspection in September 2024, the FDA identified serious violations of GMP requirements for the manufacture of active pharmaceutical ingredients (APIs) at an Indian facility. Particular focus was placed on the release of API batches affected by a fire and on deficiencies in the stability program.

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The ECA regularly reports on FDA Warning Letters that are published on the FDA website following an FDA inspection and that reveal corresponding deficiencies. Below is an overview of ‘bizarre’ findings by the FDA, particularly from the last year.

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In July, the FDA published a warning letter to Exela Pharma Sciences, which, in addition to deficiencies in microbiological tests and inspections such as sterility tests, growth promotion tests and environmental monitoring, also included a whole series of other deficiencies. It was the consequence of an inadequate response to the FDA's previous 483 letter.

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When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?

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