The paperwork problem: How many FDA warning letters actually cite document failures

Quality control inspectors in protective gear inspecting a pharmaceutical production line in a manufacturing factory.

When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify that trust. When those records are missing or incomplete, it's harder to establish whether a drug meets quality standards.

Originally published on kivo.io, part of the BLOX Digital Content Exchange.

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