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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese drug manufacturing facility for significant CGMP violations. Among other issues, the firm performed in-house HPLC testing for internal use without audit trails and could not provide validation reports for these methods. Additionally, the company failed to adequately explain the purpose of this testing.

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During an FDA inspection of an Indian pharmaceutical manufacturer, residues were found in non-dedicated manufacturing equipment. The manufacturer had tried to rule out possible cross-contamination by testing retained samples. Read here why this is not sufficient for the FDA.

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The FDA's Center for Drug Evaluation and Research (CDER) has compiled a 10-point overview of how it fulfils its task of ensuring the quality of medicinal products. What are these 10 points?

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Two reports were recently published showing that the FDA is once again carrying out more inspections. And this is also happening in the EU - despite the MRA.

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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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