The QMN Weekly Bulletin
Pharmaceuticals / GMPs

German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban

Aug. 18, 2017
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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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