The U.S. Food and Drug Administration (FDA) has announced (May 6) that the Office of Inspections and Investigations (OII) will expand its program (pilot) of unannounced inspections beyond India and China.
As we reported earlier this year, the FDA has the authority to perform both announced and unannounced inspections. In general, inspections of relevant entities in the U.S. have been unannounced while inspections of relevant entities outside the U.S. have been pre-announced, usually several weeks before the inspection and providing multiple options. In theory, this helps to confirm that the entity will be actively manufacturing products during the inspection.
The FDA started performing unannounced inspections in India and China and is now expanding unannounced inspections to other foreign entities.
Counting all regulated products (food, drugs, biologics, and medical devices), the FDA performs 12,000 domestic inspections and 3,000 foreign inspections.
Following an inspection, the FDA classifies the inspection into one of three categories: no action indicated (NAI), voluntary action indicated (VAI) and official action indicated (OAI). An inspection finding of NAI or VAI can result in the issuance of a FDA Form 483. This data is available on the Compliance Dashboard.
FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot
FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot
The Office of Inspections and Investigations (OII), part of the U.S. FDA, will expand its program pilot of unannounced inspections beyond India and China.
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