Summary of key points
Focus first on the laboratory when examining the data integrity of contract manufacturers, FDA’s Karen Takahashi
FDA Advises Starting With the Lab When Sniffing Out Data Integrity
FDA official advises starting with laboratories when auditing contract manufacturers for data integrity. Recent warning letters and WHO notice of concern show why.
More from Manufacturing
More from Compliance
• By
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
• By
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
• By
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.