Dr. Reddy’s Laboratories, which has had multiple plants blasted by regulators, acknowledged in August that Germany had yanked its GMP certificate on a plant in India. A new report from the European Medicines Agency laid out the regulator’s concerns about potentially faked test data and dirty manufacturing conditions there.
The report, is for one of Dr. Reddy’s plants in Bachupally Village, Telangana, India, and based on an inspection Aug. 1 of the small molecule tablet and capsule formulation facility.
Among the many issues raised by the German inspection team were questions over how the Dr. Reddy’s facility systematically invalidated out-of-specification testing results, claiming they were the result of "staff errors" yet providing no evidence of that.
“Deviation- and OOS-management, but also protocol-, review- and reporting-systems are designed and executed in a way to systematically not document and report 'discrepancies, non-conformancies, incidents, unusual events,' …” putting batch manufacturing and pacing records in question, the EMA report said.
On top of those and other testing issues, regulators found “Dirty rooms and equipment,” and cleaning processes that didn’t meet standards.
The problems led Germany to immediately call for the recall of products in its market and for the EMA to rule that no more products can be shipped to the EU until another inspection can verify that problems at the plant have been fixed.
The plant cited by Germany’s oversight agency is not the same one in Bachupally that the FDA in May cited in a Form 483 with 11 observations.
The FDA's action was that latest in a string of penalties directed at Dr. Reddy's, including a three-plant warning letter in 2015 that laid out many of the same issues cited by German authorities.
More recently, the Indian drugmaker began recalling more than half a million store-brand famotidine tablets in the U.S., due to failed tests for impurities and degradation.