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In April 2024, the FDA inspected the production facility of a manufacturer in Gujarat, India. Due to several serious GMP violations, the authority has now issued a Warning Letter.

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We recently reported on the issuance of two FDA Warning Letters, which included observations on inadequate root cause analysis (RCA).  However, also in other Warning Letters issued, insufficient root cause analysis is cited and seems to be a frequent finding in FDA inspections.

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In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".

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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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