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The Quality Lowdown: On Redeploying Inspectors, API Suppliers Thanks To Coronavirus

 
• By Bowman Cox

US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.

The Quality Lowdown

While the US Food and Drug Administration redeploys investigators barred by the US State Department from conducting inspections in China due to novel coronavirus risks, the health secretary says he is open to working with Congress on legislation to help the pharmaceutical industry reduce its dependence on manufacturing in China.

Meanwhile, a pre-coronavirus inspection of a crude heparin manufacturer in China identifies irregularities in record keeping and data integrity that led to a warning letter.

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