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The nine-day FDA inspection of an Indian pharmaceutical manufacturer had already taken place in October 2023. Due to the numerous and, as the FDA itself writes, egregious GMP violations and the inadequate response to the list of deficiencies by the manufacturer, a Warning Letter has now been issued.

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A recent EU Statement of Non-Compliance with GMP attests an Indian pharmaceutical company that it does not meet GMP requirements. The problem was that critical medicinal products could have been potentially affected.

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The FDA issued a Warning Letter to a compounding facility with microbiological safety deficiencies. Deficiencies were found in deviation handling and test validation.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a contract testing laboratory in Uruguay. The inspection revealed significant CGMP violations, specifically related to the laboratory data integrity and documentation practices. Key issues included incomplete laboratory records, unreviewed out-of-specification (OOS) results, and lack of controls over electronic data and manual integrations.

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A recent EU Non-Compliance Report ("Statement of Non-Compliance with GMP") issued to a  Omeprazole manufacturer in India, lists nine major and nine minor deficiencies and leads to suspension of the respective CEP by EDQM.

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The series of FDA inspections with multiple deviations continues with another Warning Letter to a Korean company. In this case too, inadequate analytical control of starting materials and raw materials, e.g. for ethylene and diethylene glycol, is part of the deviation list.

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In March 2024, the U.S. FDA issued a Warning Letter to the company "Master Paints & Chemicals Corp." after having inspected its site in October 2023. According to the Warning Letter, the firm failed to do proper incoming control tests to identity their raw materials.

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In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA).

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As previously reported, China has revised its counter-espionage law. The issue is currently attracting increasing international attention and has now also been taken up by the Financial Times. Several rejections of inspections and one arrest have already been reported.

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At the beginning of April, the FDA published a Warning Letter to a manufacturer from South Korea. This contained a whole series of deficiencies, including a lack of validation of manufacturing processes and quality control measures, as well as a lack of testing of ingredients such as glycerine for the absence of ethylene and diethylene glycol.

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