FDA red flags data records at Aurobindo unit, stock tanks2 min read . Updated: 08 Oct 2019, 12:10 AM IST
- Lab records didn’t have complete data to ensure compliance with standards, says regulator
- Electronic audit trails show a number of interruptions during test runs between Apr 2018 and Sep 2019
NEW DELHI : 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 “variability in the characteristics" of the drug.
The regulator also said that 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 19-27 September. 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 that 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 CNBC-TV18 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.
The development comes barely two days after Glenmark Pharmaceuticals’ Baddi plant was sent a warning letter by the US FDA.
The two events triggered a sell-off in pharmaceutical stocks.
The Nifty Pharma index declined 3.4% to close at 7,148.95 points on Monday, its lowest level in six years. Glenmark’s stock declined 9.5% to end at ₹285.65.