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A US company received a Warning Letter because of problems at their CMO. The FDA points out that companies are responsible for the quality of the drugs regardless of agreements in place with CMOs.

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In August 2024, the U.S. FDA issued a Warning Letter (WL) to the Chinese company "Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd." after having inspected its site in December 2023. According to U.S. FDA Warning Letter, the firm failed to implement appropriate release specifications and analytical procedures for some of their drug products.

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The Australian authority TGA now carries out shorter inspections under defined conditions, so-called "surveillance inspections". This applies to both domestic and foreign manufacturers.

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Again, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the subject of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the newsroom of the EDQM website.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Vietnam following an inspection that uncovered several significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations include the failure to conduct proper laboratory testing for drug batches, inadequate testing to verify the identity of components, assigning expiration dates without scientific justification, and a lack of sufficient quality control measures.

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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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