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After inadequate root cause analyses had already been the subject of a Warning Letter from the FDA in mid-August, another one was published just a few days later. This time for a company in the US.

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A company in Italy recently received a Warning letter from the FDA because, among other things, deviations were insufficiently investigated.

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The Warning Letter of the US FDA to a manufacturer of non-sterile medicinal products contains a whole series of deficiencies. From microbiology to stability, various areas of quality control and quality assurance were not in compliance with GMP requirements.

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A manufacturer of pharmaceutical OTC products in Puerto Rico received a Warning Letter from the US FDA in June due to serious GMP violations. The inspection had already taken place in April 2024.

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At the beginning of August, the FDA issued a Warning Letter to a US company that had shown deficiencies in the areas of product and process control through to stability analysis during an inspection. The Warning Letter was a result of the company's inadequate response after receiving a 483 form following an FDA inspection.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Jordanian manufacturer of over-the-counter (OTC) drug products for significant violations of Current Good Manufacturing Practices (CGMP). The letter highlights violations related to laboratory and stability testing, raising concerns about the safety and quality of the company's products.

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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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