FDA’s inspection at Torrent raises concerns over investigations into OOS results

By PharmaCompass

2019-05-09

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An eight-day FDA inspection at Torrent Pharmaceuticals’ finished dosage form and active ingredient facility in India revealed concerns over investigations and process validations.

The Form 483 posted on the FDA website following the April 2019 inspection highlighted that over the past three years Torrent’s investigations into out of specification (OOS) results for finished products had concluded that almost 73 percent of them were invalid.

The FDA investigation mentions almost a dozen examples where the original failing results were invalidated without a scientifically-sound and justifiable root cause.

In addition, “review of process validation documents revealed that manufacturing batches run under a process validation protocol failed to meet requirements and quality attributes.” However, the process validation was deemed acceptable and counted towards successful manufacturing process validation.

Torrent Pharmaceuticals has been besieged with drug recalls in the United States as its ‘sartan’ products have been found to contain cancerous nitrosamine impurities, which were found to be above the acceptable daily intake limits released by the FDA.

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