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USFDA issues 1 observation for Aurobindo Pharma arm AP facility
![USFDA issues 1 observation for Aurobindo Pharma arm AP facility USFDA issues 1 observation for Aurobindo Pharma arm AP facility](https://medicaldialogues.in/h-upload/2022/10/20/750x450_188526-usfda-inspection-new.webp)
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued a ‘Form 483’ with 1 observation at the end of the inspection at Unit IV, a Formulation manufacturing facility, of APL Healthcare Limited, a wholly-owned subsidiary of the Company, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh.
The inspection was held from September 13 to September 19, 2023
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 gets USFDA EIR for Telangana facility
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 25 manufacturing and packaging facilities that are approved by leading 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 multiple therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Read also: USFDA tentative nod to Aurobindo Pharma's generic FDC drug to treat HIV in children
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