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Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.

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With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.

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The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.

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The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

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The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

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In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

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Deviations and CAPA are still hotly debated topics in GMP inspections. This is shown once again by a recent Warning Letter issued by the U.S. FDA.

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The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.

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The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

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The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.

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