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US FDA issues 6 observations to Aurobindo's Unit 12

Updated : March 11, 2020 11:31 AM IST

US FDA had inspected Aurobindo Pharma's Unit 12 from February 10, 2020 to February 14, 2020 and from February 17, 2020 to February 21, 2020 and had issued 6 observations.

Unit 12 is a formulations facility for Aurobindo Pharma. It manufactures antibiotics, oral solid dosages and injectables.

CNBC-TV18 has accessed Form 483 issued to this unit.

According to the US FDA observations, the facilities at Unit 12 are not adequate to ensure prevention of contamination, procedures to prevent microbio contamination are not established, employees lack education and training required. They also failed to thoroughly review the unexplained discrepancy, procedures describing handling of complaints were deficiently written and followed, and sensitivity of test methods are also not established.

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