CNBC TV18 reported that the company's unit-7 was inspected from September 19-27 by USFDA, which issued seven observations, including failure to thoroughly review any unexplained discrepancy.
Aurobindo Pharma plunged 19.16 percent to end at a five-year low of Rs 458.50 on BSE on October 7 after reports that the company had received USFDA's adverse observation for its unit-7.
CNBC TV18 reported that the company's unit-7 was inspected from September 19-27 by the US Food and Drug Administration. The American drug regulator issued seven observations, which included failure to thoroughly review any unexplained discrepancy.
Failure to thoroughly review the failure of a batch or any components, no written procedures for the production and process controls were the other observations made by USFDA.
The drug regulator also highlighted that the control procedures were not established, while lab records didn't include complete data derived from all tests.
Responsibilities and procedures applicable to quality control were not fully followed, equipment and utensils were not cleaned at appropriate intervals, USFDA said.
The promoters of Aurobindo Pharma have come in as white knights to fund entrepreneur Dr T Gurunath Reddy in his buy-out of the stake held by IHH Healthcare-backed Parkway Pantai in the Hyderabad-based Continental Hospitals in Rs 600-crore deal.
Continental Hospitals is at present majority-owned and controlled by Gleneagles Development Pte Ltd (GDPL), a subsidiary of Parkway Pantai, a Singapore and Kuala Lumpur-based healthcare provider owned by the IHH.The promoters of Aurobindo would be doing the deal in their personal capacity, one of the sources told Moneycontrol. The funds will help Reddy, a gastroenterologist, to ring-fence Continental Hospitals from other prospective buyers.The Great Diwali Discount!
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