FDA red flags data records at Aurobindo

NEWDELHI: The US Food and Drug Administration (FDA) has issued seven adverse observations to one of Aurobindo Pharma’s Telangana units, criticising it for not keeping complete data records and for providing “potentially misleading” documents during inspection.

“Several lists of documents requested were either provided as incomplete, inaccurate, and/ or explained with potentially misleading statements throughout the inspection,” US FDA said in one of its observation in a Form 483 notification issued on 27 September for Aurobindo’s Telangana unit.

Electronic audit trails revealed a number of interruptions during test runs between April 2018 and September 2019, but the company failed to review these trails and assess what caused the issues, the FDA said.

The US regulator added that the laboratory records at the facility did not have complete data of all tests necessary to ensure compliance with established standards.

In another observation, it said that control procedures at the facility did not establish which manufacturing process was responsible for causing “varia

FDA CRITICIZED IT FOR NOT KEEPING COMPLETE DATA RECORDS AND FOR PROVIDING ‘POTENTIALLY MISLEADING’ PAPERS DURING INSPECTION

bility in the characteristics” of the drug.

The regulator also said there were no written procedures for production and process controls to assure quality, and that the responsibilities and procedures applicable to quality control were not fully followed. Besides, it was not satisfied with the cleanliness of the equipment and utensils used to manufacture medicines.

The observations were made after an inspection during September 19-27. A copy of the Form 483 was reviewed by Mint.

In a clarification to the exchanges, Aurobindo Pharma on Monday said it believes “none of the observations are related to data integrity”. However, Surajit Pal, an analyst with Prabhudas Lilladher, said the observations indicate data integrity issues. “The insinuation in the Form 483 is that there were data integrity issues. So the observations are very serious. Now, it remains to be seen what line of argument the management will take with the US FDA on the observations,” said Pal.

The US FDA also said the generic drug application of the company for dutasteride and tamsulosin hydrochloride is currently under review. Aurobindo Pharma’s unit VII manufactures non-penicillins, non-cephalosporins and anti-retroviral medicines, according to the company’s website. After CNBCTV18 reported that the plant had received a warning letter, Aurobindo Pharma’s stock fell as much as 20.6% on Monday, its steepest in over eight years.

The stock ended 20.4% lower at ₹451.70 on the NSE.