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Drug Approval | April 14, 2024
Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
This facility manufactures APIs & formulations of oncology and non-oncology products.
This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
The company is confident of addressing the concern raised by the USFDA
Vision loss due to Glaucoma can be prevented if it is detected and treated early
The observations do not pose any risk to site's compliance standards or its business continuity
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
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