Last Updated on October 9, 2024 by The Health Master
The US Food and Drug Administration (USFDA) issued an Establishment Inspection Report (EIR) in connection with the inspection of the business’s flagship facility in Bangalore, India, according to Strides Pharma Science.
The USFDA visited the company’s main facility between December 5 and December 9, 2022, and a form 483 with three inspectional observations was produced as a result.
Based on the company’s response to the observations and subsequent commitments, the USFDA has classified the outcome of this inspection as VAI (voluntary action indicated), and the EIR states that the inspection is closed.
The flagship facility of Strides in Bangalore is the largest manufacturing facility for the company, with the capability to produce finished dosage formulation products across multiple dosage formats, including tablets, capsules, ointments, creams, and liquids.
The facility services the key regulated markets of the US, Europe, and Australia.
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