Aurobindo Pharma USA New Jersey warehouse gets USFDA OAI status
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) had conducted an inspection at one of the warehouses of Aurobindo Pharma USA Inc., (a 100% subsidiary of the Company), situated at East Windsor, New Jersey, from May 13, 2024 to May 15, 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA).
The inspection had concluded with 5 observations.
Subsequently, the US FDA has determined the inspection classification status of this warehousing facility as ‘Official Action Indicated (OAI)’.
"At this point in time, the Company doesn’t foresee any impact on the business. The Company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis," Aurobindo stated.
Read also: Aurobindo Pharma arm Eugia Steriles gets 5 UFSDA observations
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.
Read also: Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU
