Recipient: C & M Oxyfill LLC.
Product: Compressed Oxygen USP
Date: 5/26/05
Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your firm has not performed any equipment qualification on the “mobile” cryogenic pumping system which transfills your Compressed Oxygen, USP, drug product. The qualification of this system is especially crucial, because the system’s manufacturer (a contract firm named _____ states in its documentation, it typically manufactures stationary pumping systems and “does not vouch for the operation of an Oxygen filling system in a portable trailer configuration.” _____ also states C & M Oxyfill requested they fabricate and install this mobile cryogenic pumping system according to C&M Oxyfill’s layout and design.
FDA District: New Orleans District Office
