Granules Pharma facility gets 5 USFDA observations
Hyderabad: Granules India Limited has announced that the United States Food and Drug Administration (USFDA) has concluded a GMP inspection with five observations at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA.
The inspection was held from 11th December 2023 through 15th December 2023.
"USFDA has completed a GMP inspection of the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA from 11th December 2023 through 15th December 2023 with five observations," Granules informed in a recent BSE filing.
"Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time and does not anticipate any disruptions to its business," the Company added.
Read also: Granules India bags USFDA nod for Pantoprazole Sodium Delayed Release Tablets
Medical Dialogues team had earlier reported that Granules Pharmaceuticals, Inc. had successfully completed the USFDA Post-marketing Adverse Drug Experience (PADE) Inspection for all its entities in the United States, including Granules India Limited.
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.