503B Outsourcing Facility FDA Registration COI
What this clause says
Vendor warrants its current registration as a 503B Outsourcing Facility with the FDA and shall provide a Certificate of Insurance reflecting cGMP-aligned property coverage, products liability of not less than $5,000,000 per occurrence, and product recall extension covering FDA-mandated recalls.
What this means in plain English
503B outsourcing facilities are FDA-registered drug manufacturers under section 503B of the FDCA. Hospital purchase contracts with 503Bs typically require cGMP-aligned property coverage, $5M-$10M products liability, and FDA-specific recall extensions.
What it means for a CDMO program
A 503B outsourcing facility carrying a generic compounding-pharmacy program will fail hospital procurement insurance reviews. The cGMP environment changes the property exposure (validation losses, batch losses, cleanroom contamination), and large-batch production amplifies recall stakes vs. patient-specific 503A operations.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- fda503 b › registered is set → Compliant: FDA-registered 503B status documented.
- fda503 b › registered is not set → Gap: No FDA 503B registration documented — required for outsourcing-facility hospital contracts.
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