USFDA concludes inspection at Gland Pharma Visakhapatnam facility with zero 483 observations
Telangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has conducted Good Manufacturing Practice (GMP) Inspection at the Company’s VSEZ Sterile Oncology Facility at Visakhapatnam between 20th July, 2023 and 28th July, 2023.
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.
Medical Dialogues team had earlier reported that the company had received zero observations from the USFDA after an inspection at the company's API Facility at JNPC, Visakhapatnam.
Read also: USFDA issues zero observations for Gland Pharma Visakhapatnam API facility
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.
Read also: Gland Pharma gets one 483 Observation from USFDA for Dundigal facility
