USFDA completes inspection at Aurobindo Pharma’s Raleigh unit with 1 observation

29 Aug 2022 Evaluate

United States Food and Drug Administration (USFDA) has completed inspection at Aurobindo Pharma’s wholly owned step down subsidiary -- Aurolife Pharma LLC unit at Raleigh, North Carolina, USA. USFDA has issued 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues.

USFDA had conducted its pre-approval inspection (PAI) and GMP inspection from August 22 to August 26, 2022, established for manufacturing MOI (Metered Dose Inhalers) and Derma products. The Unit has filed 2 Derma products and 1 MOI product.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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