Drug Approval | June 23, 2025
Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
Speakers for the session are: Dr. Richard Lobo, Global Head Business Excellence, Innovation, R&D and Chief Ethics Counsellor, Tata Chemicals; Dr. Debabrata Rautaray, Vice President and Chief Product Development & Innovation Officer, DCM Shriram Chemicals Innovation Centre; Dr. Prashant Puri, Head - R&D, Deepak Fertilizers and Petrochemicals Corporation (DFPCL); Dr. Deepak S Panmand, General Manager (R&D), Dhanuka Agritech; Dr. Mudassir. K. Munshi, Team Leader, Deepak Nitrite; and Dr. Manish M. Khandagale, Senior Field Application Specialist, Revvity Signals
These observations are procedural in nature and none of them are related to data integrity
The Subsidiary has received one inspectional observation in Form 483
The inspection concluded with 6 observations and none of them were related to Data Integrity
Distribution agreement enables FUJIFILM India to offer Spectra Logic advanced tape libraries and software solutions to enterprise customers and channel partners
By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11
Collaboration combines data, identity capture and Web 3.0 crypto technologies to enhance product safety, traceability, and data integrity for AI systems
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
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