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    • Aurobindo Pharma gets...

    Aurobindo Pharma gets 14 USFDA observations for Pashamylaram facility

    Farhat NasimBy Farhat NasimPublished On 2019-11-15T12:13:45+05:30  |  Updated On 2021-08-16T14:37:30+05:30

    The US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad from November 4-13, Aurobindo Pharma said.


    New Delhi: Aurobindo Pharma has received 14 observations from the US health regulator for its Hyderabad-based plant, according to a regulatory filing.


    The US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad from November 4-13, Aurobindo Pharma said.




    "At the end of the inspection, we have been issued a Form 483 with 14 observations," it added.


    Also Read: Aurobindo Pharma gets 8 USFDA observations for 2 facilities in Hyderabad


    The company believes that none of the observations are related to data integrity issues and, it will respond to the USFDA within the stipulated timeline, Aurobindo Pharma said.


    The observations issued by the USFDA notifies the company's management of objectionable conditions at the inspected facility.


    Read Also: Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA
    Aurobindo Pharma Hyderabad injectable manufacturing unit Pashamylaram facility USFDA USFDA form 483 USFDA inspection 
    Source : PTI

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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