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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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End of August 2024, the U.S. FDA issued a Warning Letter to the company "Orean Personal Care Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to do proper incoming control tests for identity of their raw materials.

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The US FDA inspected a CGT manufacturer of CAR T cells used in a Phase 2 clinical trial in November 2023 and has now issued a Warning Letter due to GMP violations.

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The FDA issued a Warning Letter in response to a large number of deficiencies found during an inspection at an Indian manufacturer with aseptic production - and which were not answered with a sufficient catalogue of measures.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. The company failed to conduct necessary quality testing on their drug products, including testing for active ingredients and raw materials. Additionally, there were issues related to process validation, equipment cleaning, and facility maintenance.

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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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