Aurobindo Pharma drops 5% on USFDA observations

Shares of Aurobindo Pharma declined 4.83 per cent in Friday's session after USFDA pointed out data integrity lapses at the company's finished dosages plant at Bachupally in Telangana.

The FDA issued Form 483 with 10 observations to Aurobindo Pharma on the plant which was audited by the US drug regulator between May 13 and May 24, PTI reported on Thursday.

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

The shares of the company closed 3.20 per cent lower at Rs 616.30 on BSE.