USFDA completes inspection at Gland Pharma’s VSEZ Sterile Oncology facility with Zero observations

Gland Pharma has reported that between July 20 and July 28, 2023, the company’s VSEZ Sterile Oncology Facility in Visakhapatnam undertook a Good Manufacturing Practises (GMP) Inspection by the US Food and Drug Administration (US FDA). 

The inspection was concluded with Zero 483 observations and a classification of No Action Indicated (NAI). No action indicated (NAI), means no objectionable conditions or practices were found during the inspection. 

The Medical Dialogues team had previously said that following an inspection of the company’s API Facility at JNPC, Visakhapatnam, zero observations had been made by the USFDA. 

Gland Pharma, a generic injectable-focused pharmaceutical company was established in 1978 in Hyderabad. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

Source: Media Reports