News | September 05, 2025
FDA completes inspection at Biocon Biologics' facility in Bengaluru
The U.S. FDA issued a Form 483 with five observations
The U.S. FDA issued a Form 483 with five observations
This will be Aster’s fifth hospital in Bengaluru
This partnership aims to address the growing demand for high-quality diagnostics in metropolitan areas
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Plans underway to expand screening capacity by 50% for greater accessibility
Expansion makes Merck Life Science in Bengaluru a key manufacturing location in the APAC region
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
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