Aurobindo Pharma falls 5% after USFDA points out data

Aurobindo Pharma shares fell 5 percent intraday on June 14 after the US health regulator pointed out data integrity lapses at finished dosages plant in Bachupally, Telangana.

The US Food and Drug Administration issued Form 483 with 10 observations on the plant which was audited by the US drug regulator between May 13 and May 24.

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards, the FDA said.

Specifically, there is no adequate data integrity program in place to include an adequate review of all electronic raw data by the quality unit to ensure completeness, consistency, and accuracy of all chromatographic raw data generated by the quality control (QC)laboratory, it said as one of the observation.

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