Dr Reddy’s has received a Form 483 with eight observations from the US Food and Drug Administration following an inspection that took place from 12-20 August 2019 at its oncology injectables plant in Duvvada, Andhra Pradesh . According to the observations made by the FDA investigators, “the quality control unit lacks authority to fully investigate errors that have occurred” and “aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air-filters under positive pressure.”
Manufacturing Round-Up: Dr Reddy’s Receives Another Form 483
Dr Reddy’s, Ipca Labs and Yino have received Form 483s over quality control issues. Meanwhile, Bora Pharma, Unichem and Laurus Labs have successful FDA inspections and Indoco Remedies gets its GMP status fully reinstated.
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