STAT+: Intas Pharma employee used acid to destroy manufacturing records at troubled plant
The FDA says an Intas Pharmaceuticals employee used acid to destroy manufacturing records at a troubled plant in India.
Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility.
Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash. Plastic bags filled with torn and discarded important production records were stashed under a stairwell and on a truck parked outside. Laboratory data, in some cases, went missing. The company also failed to validate processes to ensure strength, quality and purity of its medicines.
These serious violations of manufacturing protocols were revealed in a July 28 warning letter sent by the U.S. Food and Drug Administration in response to an inspection late last year at the Intas facility in Sanand, India. Some details were previously disclosed in an FDA inspection report made public, but the letter provides added information and context about agency concerns.
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