Last Updated on December 31, 2023 by The Health Master
The Gland Pharma received a zero-observation certificate on Form 483 from the United States Food and Drug Administration (USFDA) for its Visakhapatnam facility.
The USFDA conducted the good manufacturing practice (GMP) inspection at the company’s VSEZ Sterile Oncology facility at Visakhapatnam between July 20 and July 28.
The inspection concluded with zero observations on Form 483 and a classification of No Action Indicated (NAI).
On July 14, the company received one observation after the USFDA conducted a GMP inspection at Dundigal facility at Hyderabad during July 3-14.
The regulator had last month issued one observation on the company’s Pashamylaram facility at Hyderabad after GMP and pre-approval inspection (PAI) for seven products.
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