U.S. FDA Points Out Data Integrity Lapses At Aurobindo Pharma Unit
Employees work in the warehouse of an Aurobindo Pharma Ltd. production facility in Jadcherla, India. (Photographer: Prashanth Vishwanathan/Bloomberg)

U.S. FDA Points Out Data Integrity Lapses At Aurobindo Pharma Unit


The U.S. Food and Drug Administration has pointed out data integrity lapses at Aurobindo Pharma Ltd.’s finished dosages plant at Bachupally, Telangana.

The U.S. FDA issued Form 483 with 10 observations to Aurobindo Pharma on the plant which was audited by the U.S. 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 laboratory, it said as one of the observation.

Reacting to the FDA observations, Aurobindo Pharma on June 4 said, "the company will be responding to the U.S. FDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility.”

Aurobindo Pharma received Form 483 with 11 observations for one of its units located in a Special Economic Zone in Telangana earlier this year.

As per the U.S. FDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

Shares of the company fell as much as 5.4 percent intraday to Rs 602.80 compared to 0.5 percent fall in Nifty Pharma Index, in today’s trade.

BQ Install

Bloomberg Quint

Add BloombergQuint App to Home screen.