If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA). With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status. With so much riding on any given inspection, what do you do if problems arise with […]
In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations. As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory […]
As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection. At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law […]
