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Prabhudas Lilladher Report
The Unit-I of Aurobindo Pharma Ltd. is active pharma ingredient manufacturing unit of cardiovascular, central nervous systems, anti-allergies and non-sterile Ceph products located in Medak, Telangana, India.
As the plant is currently under Warning Letter, U.S. Food and Drug Administration carried out long pending current good manufacturing practice audit in the plant during August 02 to 12, 2021 and concluded with seven observations of Form-483.
While there were no issues of data integrity and repeat observations, its seven observations raised concerns over quality of data maintained at the plant, as Aurobindo Pharma documented outcome of action/tests after a lag.
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