Indian Pharma Strides Pharma Science Ltd. Shreds Quality Documents Ahead of FDA Inspection

Jul 18, 2019 | GMC, GxP, Quality Assurance, Quality Control Records

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India-based Strides Pharma Science, Ltd sells numerous drugs in the United States including ibuprofen. They were recently caught attempting to dispose of quality-control records, calling into question the safety of its medicines and the integrity of its quality assurance organization.

Bloomberg reports that US FDA inspectors found evidence of shredded quality documents at their manufacturing facility in Puducherry the agency reported in a warning letter. Discarded records were also found in a 55-gallon drug in the company’s scrapyard. These are suspect data points. Follow the link to Bloomberg to review.

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