Suven Pharma arm Hyderabad facility gets USFDA EIR
Maharashtra: Suven Pharma has announced that Casper Pharma Private Limited, a Wholly Owned Subsidiary of the Company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the formulations manufacturing facility located in Hyderabad.
The US FDA has categorized the inspection as "Voluntary Action Indicated" (VAI) and has deemed it as "closed" under 21 CFR 20.64(d)(3).
Voluntary action indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Read also: Suven Pharma to buy 67.5 percent stake in Sapala Organics for Rs 229.5 crore
Medical Dialogues team had earlier reported that the USFDA had issued 2 observations for the Casper Pharma Private Limited in Hyderabad, a WOS of the company
Read also: Casper Pharma gets 2 USFDA observations
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