FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities
By Sharry Arora -
Published 14 July 2017
The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).
Categories: Features, US, FDA, Compliance, Drugs, Manufacturing
Tags: Oral Solid Dosage, OSD, Inspections