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The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter highlighting critical violations of Current Good Manufacturing Practice (CGMP) regulations, which cover the manufacturing and analytical testing of drug products.

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In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.

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According to FDA sources, numerous FDA inspections are still being carried out in the EU. Why is that?

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The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Massachusetts-based company, highlighting serious compliance issues. Notably, many of these problems, such as product crystallization and potential lead contamination, seem to have been addressed only because the FDA initiated an inspection.

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The Swiss health authority Swissmedic launched a SwissGMDP database, similar to the EudraGMDP database, listing GMP and GDP certificates of all companies in Switzerland.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. drug manufacturer for violating Current Good Manufacturing Practice (CGMP) regulations. Key issues include the failure to test raw materials for identity and purity, particularly for high-risk components like glycerin and sorbitol. The company also lacked an effective quality control unit to oversee product safety.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Canadian company following an inspection that revealed significant CGMP violations at their drug manufacturing facility. The violations included failure to perform identity testing on drug components, inadequate process validation, and lack of proper oversight by the quality control unit. These issues were identified despite the FDA previously issuing a Warning Letter about similar problems.

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End of August 2024, the U.S. FDA issued a Warning Letter to the company "Orean Personal Care Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to do proper incoming control tests for identity of their raw materials.

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The US FDA inspected a CGT manufacturer of CAR T cells used in a Phase 2 clinical trial in November 2023 and has now issued a Warning Letter due to GMP violations.

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The FDA issued a Warning Letter in response to a large number of deficiencies found during an inspection at an Indian manufacturer with aseptic production - and which were not answered with a sufficient catalogue of measures.

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