USFDA issues 3 observations to Aurobindo Pharma's Unit-XI

Aurobindo Pharma (Representative image)

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

The Unit-XI plant produces non-antibiotic active ingredients, is used for both the captive purpose of Aurobindo‘s formulation manufacturing and for supplies to external customers.

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

Aurobindo’s Unit XI was inspected by US FDA between July 25 and August 2, 2022. Network 18 accessed form 483 issued to Aurobindo Pharma's Unit 11.

According to US FDA observations, the procedures for cleaning and maintenance are deficient. The unit has failed to explain any unexplained discrepancy and the responsibilities and procedures for quality control are not fully followed.

At 12:25 pm, shares of Aurobindo Pharma traded 0.44 percent to Rs 544.60 apiece on the BSE.

Earlier in the year, the US drug regulator had inspected Aurobindo Pharma's Unit-VII and issued six observations. Unit-VII is Aurobindo Pharma's oral manufacturing facility situated at Jedcherla, Hyderabad. Aurobindo's Unit 7 was issued official action indicated status from US FDA in 2020.