US FDA finds adulteration and 'significant violations' at India's Strides plant
Reuters July 17, 2019
The U.S. Food and Drug Administration (FDA) said it found adulteration and "significant violations" of current good manufacturing practice (CGMP) regulations at Strides Pharma Sciences Ltd's plant in Puducherry in south India.
Strides shares fell 5% in early trade on Wednesday.
The drugmaker was caught trying to dispose quality-control records, the FDA said in a letter made public on July 16.
"Our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents," it said.
The FDA's warning letter here dated July 1, comes months after several Indian drugmakers including Sun Pharmaceutical Ltd and Dr.Reddy's Laboratories Ltd were named in a U.S. lawsuit against Israeli drugmaker Teva Pharmaceutical Industries Ltd accusing it of conspiring to inflate drug prices and stifle competition for generic drugs.
Last month, Aurobindo Pharma Ltd was warned here by the FDA for ignoring impurities in an active ingredient it produced. Hyderabad-based Aurobindo recalled contaminated valsartan in January and in March.
The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe "raise questions about the effectiveness" of Strides's quality unit "and the integrity and accuracy" of its data, Francis Godwin, director of the FDA's Office of Manufacturing Quality, wrote in the letter.
On July 2, Strides shares slumped after it said it received a warning letter from the U.S. FDA, it did not disclose the content of the letter at that time.
Strides did not immediately respond to a request for comment, while the U.S. FDA was unavailable for further comments outside regular business hours.