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USFDA inspects Aurobindo Pharmas unit at Raleigh North Carolina USA

2 Sep 2022 , 01:33 AM

Aurobindo Pharma announced that the United States Food and Drug Administration US FDA conducted its pre-approval inspection PAI and GMP inspection from 22 August to 26 August 2022 of Unit at Raleigh North Carolina USA owned by Aurolife Pharma LLC a wholly owned subsidiary of the company established for manufacturing MDI Metered Dose Inhalers and Derma products The Unit has filed 2 Derma products and 1 MDI product At the end of the inspection Aurolife has been issued a Form 483 with 1 observation and the observation is procedural in nature and there are no data integrity issues

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