The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
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