Aurobindo Pharma gets 1 USFDA observation for Sangareddy facility

Published On 2023-09-30 08:00 GMT   |   Update On 2023-09-30 08:00 GMT
Advertisement

Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has issued 1 observation after the inspection at Unit VI - B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana.

The facility was inspected between September 22 to September 29, 2023.

"At the end of the inspection, a ‘Form 483’ was issued with 1 observation which is procedural in nature. We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest," Aurobindo stated.
Advertisement

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, Hilleman Labs Singapore ink pact for paediatric pentavalent vaccine

Medical Dialogues team had earlier reported that the Company had received Voluntary Action Indicated (VAI) from the US health regulator for its Telangana-based manufacturing plant.

Read also: Aurobindo Pharma Telangana facility gets VAI classification 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 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.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News