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Structured, FEI-mapped FDA GMP inspection observation database covering 2008-2026: each observation record carries the FDA Facility Establishment Identifier, legal entity name, inspection end date, the specific Act/CFR citation breached, the programme-area system classification (Quality, Facilities & Equipment, Laboratory Controls, Production, Packaging & Labelling), the full observation narrative, and a mapped link to the source Form 483 and any related warning letter, with country-level and programme-area trend aggregation on top
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