Gland Pharma Visakhapatnam facility gets USFDA EIR
Hyderabad: Gland Pharma, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the Company has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) indicating closure of the inspection at its facility at JNPC, Visakhapatnam.
The USFDA had conducted a Pre-Approval Inspection (PAI) for Sterile Active Pharmaceutical Ingredients (APIs) at the site from February 19 to February 25, 2025.
Read also: Gland Pharma ropes in Wriddhee Maitra as Vice-President (Human Resources)
Medical Dialogues team reported in February that the company had received three Form 483 observations from the USFDA following the inspection.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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