Strides Pharma Science announced that the US Food and Drug Administration (US FDA) issued an Establishment Inspection Report (EIR) concerning the inspection of the Company's flagship facility in Bengaluru.
The company's flagship facility was inspected by the US FDA between December 5 and 9, 2022, and a form 483 listing three inspectional observations was issued. Based on the company's response to the observations and subsequent commitments, the US FDA has classified the outcome of this inspection as VAI (voluntary action indicated), and the EIR states that the inspection is closed.
The flagship facility in Bengaluru 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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