Gland Pharma gets 3 USFDA observations for Visakhapatnam facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-26 06:00 GMT | Update On 2025-02-26 06:00 GMT
Advertisement
Hyderabad: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with three observations at the Company’s Facility at JNPC, Visakhapatnam.
A Pre-approval inspection (PAI) for Sterile APIs was held between February 19, 2025 and February 25, 2025.
Conclusion of US FDA Inspection at Company’s JNPC Facility, Visakhapatnam
The said inspection was concluded with THREE (3) Form 483 Observations.
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.
"These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity," Gland stated in a 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.