Aurobindo Pharma arm Unit IV gets 5 USFDA observations

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-12-18 06:00 GMT | Update On 2025-12-18 06:00 GMT

Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued five observations at the end of the inspection at Unit-IV of APL Healthcare, a wholly owned subsidiary of the Company, situated at Palchur village and part of Palepalem Village Naidupeta Mandal, SPSR Nellore District, 524126, Andhra Pradesh.

USFDA inspected the facility from December 08 to December 17, 2025.

"At the end of the current inspection, a ‘Form 483’ was issued with 05 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines," the company stated in a BSE filing.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Read also: Aurobindo Pharma arm API facility gets EIR from USFDA

"The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," Aurobindo stated.

This development doesn’t have any impact on financials & operations of the facility.

Read also: Aurobindo Pharma arm API facility receives 3 observations from USFDA

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 31 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 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a R&D set-up.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Aurobindo Pharma arm Unit IV gets 5 USFDA observations

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