Aurobindo Pharma arm gets 11 USFDA observations for Raleigh Plant
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has issued 11 observations after an inspection at Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, established for manufacturing Inhalers and Derma products.
The inspection was conducted from March 24, 2025 to April 10, 2025.
As per the Company, the inspection was completed on April 10, 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations.
"These observations are procedural in nature. We will submit a comprehensive response to the USFDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions. The Company is committed to maintaining the highest standards of quality and compliance across all its operations. We do not expect this development to have any material impact on the current business operations or existing supplies from this facility," Aurobindo stated in a BSE filing.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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