Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions

Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions

July 3rd, 2022 // 3:55 pm @

Generic drug manufacturer Aurobindo Pharma based in India has been under the gun from FDA for years, but now the company is getting unwanted attention from Indian regulators.

The website Business Standard in India reported last month that the company was sent a warning letter from the Security Exchange Board of India (SEBI).

The warning letter was related to disclosures the company made regarding an FDA inspection of the firm’s API facility in Hyderabad. Also of concern were the FDA observations made from 2019 to 2022.

The Business Standard states that the Indian warning letter noted that the firm had disclosed very limited information about its facilities. However, the letter didn’t consider the FDA observations about its cGMP practices as serious. SEBI advised the firm to ensure that it is in compliance with the regulations laid out by SEBI and to put this warning letter in front of management.

Aurobindo’s Unit 1 received a 483 after an inspection in August 2021 and seven observations were made by the auditors. The 483 noted equipment wasn’t properly maintained and systems for reviewing critical materials were not tested and released before they were used.

However, FDA has given the company other 483s recently. In June, FDA made several 483 observations at the company’s Unit VII drug formulation plant in Polepally, India, after an early May inspection.

FDA investigators found discrepancies and failed batches that didn’t meet company specifications. There also weren’t written procedures for process controls and production, as well as control records and batch production lacking complete information.

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