Aurobindo Pharma Sangareddy facility gets 10 USFDA observations
Advertisement
Hyderabad: Drugmaker Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with 10 observations at the Company's Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana.
The facility was inspected from November 10 to November 18, 2022.
The said Unit had been classified as OAI on May 17, 2019, and the Company had responded to the agency and carried out the required corrective actions.
The US FDA Authorities have reinspected the facility as mentioned above. At the end of the inspection, the Company has been issued a 'Form 483' with 10 observations.
"In our view, these observations are procedural in nature and not related to data integrity. The Company will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest," the company stated in a recent BSE filing.
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 .
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.