USFDA issues six observations to Aurobindo Pharma's Unit-VII

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26 Aug, 2025 12:21

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US Food and Drug Association (FDA) inspected Aurobindo Pharma's Unit-VII and issued six observations.

Unit-VII is Aurobindo Pharma's oral manufacturing facility situated at Jedcherla, Hyderabad. It is ultra-modern unit based on the suite manufacturing concept delivering huge capacity, and manufactures non penicillins, non cephalosporins and antiretrovirals (ARVs).

Also Read: Aurobindo Pharma hits 52-week low after six observations from US

Aurobindo's Unit 7 was issued official action indicated status from US FDA in 2020. Network 18 accessed form 483 issues to Aurobindo Pharma's Unit 7.

According to US FDA observations, that facilities at Aurobindo Pharma's Unit 7 does not follow written procedures for production or process controls. Its batch production and control records do not include complete information and written stability testing program is not followed at the facility. Appropriate controls are not exercised over computers or related systems, while the equipments used are not of appropriate design.

The investigations of unexplained discrepancy and a failure of a batch did not extend to other batches, according to US FDA observations.

At 12:58 pm, shares of Aurobindo Pharma traded two percent lower at Rs 539.75 apiece on the BSE.