U.S. FDA issues four observations to Gland Pharma facility near Hyderabad
Regulators issued the Form 483 notices following an unannounced good manufacturing practice inspection at the Dundigal formulation facility.
The United States Food and Drug Administration has issued four Form 483 observations to a Gland Pharma formulation facility situated near Hyderabad. The regulatory notices follow a recent assessment of the pharmaceutical plant, which is located in Dundigal.
Regulators conducted an unannounced inspection of the site to evaluate its adherence to current good manufacturing practice. The on-site examination took place over an eleven-day period, beginning on October 12 and concluding on October 23.
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