Aurobindo Pharma Unit-1 gets 7 observations; company says responding to USFDA

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26 Aug, 2025 12:21

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Aurobindo Pharma Unit-1 that makes active pharmaceutical ingredients (APIs) has received seven Form 483 observations from USFDA. Unit-1, located in Medak, Telangana manufactures APIs related to the cardiovascular, central nervous system, CNS, anti-allergics and non-sterile Cephalosporins.

The inspection was carried out between August 2 - 12.

The latest observations include inadequate evaluation and qualification of critical material suppliers, inadequate sampling plans for raw materials and intermediates, components used in manufacturing are not tested and released prior to use, proposed changes are not adequately evaluated, quality control failed to ensure investigations were scientifically sound and equipment not properly maintained and document at the time of performance, according to CNBC-TV18 report.

There are no repeat observations or anything related to data integrity; we are in the process of submitting our response to the USFDA, said the spokesperson of Aurobindo Pharma.

Form 483 is issued by USFDA inspectors at the end of an inspection, where they list their observations related to any discrepancies in the current good manufacturing practice (cGMP).

Aurobindo Pharma's Unit-1 was classified by USFDA for official action indicated in May 2019. The company submitted its corrective and preventive action plan, following which the agency came for reinspection.

Shares of Aurobindo Pharma slipped 3.59 percent and were trading at Rs 696 on BSE at 10.50 am; the benchmark Sensex declined 0.65 percent to 55,265.21 points.