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Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.
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.
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.