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Home » German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban
German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings.
At the company’s FTO 2 plant in Hyderabad, German inspectors found hundreds of out-of-specification results in product checks, attributed to “staff errors” without the required analysis of root causes, according to a report from EudraGMP.
The company’s monitoring systems are designed and executed in a way to systematically not document and report discrepancies, non-conformances, incidents or unusual events, the report said.
The FDA previously identified GMP problems at multiple Dr. Reddy’s sites, issuing a Form 483 report earlier this year and a warning letter in 2015.
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