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 concluded with few procedural observations
The company has received Form 483 with three observations
NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
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