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A US contract manufacturer of sterile over-the-counter and homeopathic ophthalmic products received a Warning Letter from the FDA due to problems in aseptic manufacturing and room conditions, among other things.

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The FDA carried out an inspection at Jiangsu Hengrui in January 2024. Initial results have now been published in a so-called Form 483. The number and severity of the observations is alarming.

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The FDA found numerous GMP violations during an inspection of a Korean manufacturer of an OTC sunscreen product. Among other things, the water system was criticized.

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The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese company based on a review of records. Key issues include failure to adequately test the identity of incoming components, lack of process validation, and inadequate laboratory testing of finished drug products.

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At the beginning of July, the FDA published a Warning Letter due to a lack of chemical and microbiological controls in the manufacture of a product for dermal application and inadequate testing of the ingredients used.

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The FDA rarely goes into great detail about expected measures in its Warning Letters, especially not when it comes to instructions on the desired procedure. This is now different in a Warning Letter that was published in July. It describes in considerable detail what the FDA considers to be appropriate CAPA measures in a specific case.

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In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected its site in January 2024. According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests to identity the goods.

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"Warning Letters" for FDA: Two recent letters from Congress to the FDA Commissioner highlight ongoing and historical challenges within the FDA's foreign drug inspection program, even raising concerns about inspector competence.

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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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