A late-July FDA warning letter to medical gas supplier Nitrox notes that several of the violations cited were cited also in 2003 and 2000 in Form 483s. "The most recent inspection found that your firm has failed to implement sufficient corrective actions and many of the same violations persist."
The company has failed also to complete its annual registration with the regulator, the letter says. As a result, "liquid Nitrogen NF and Dolonox are misbranded in that they were manufactured in an establishment not registered as required."
The most recent citations include absence of finished product testing on filled cylinders of Dolonox, a 50 percent USP Nitrous Oxide and 50 percent USP Oxygen compressed gas mixture. The regulator says the company released high-pressure cylinders of the gas without testing for identity and strength.
The letter cites the company also for a lack of "scientifically sound and appropriate" specifications, standards, sampling plans and test procedures for product identity, strength, quality and purity standards. Batch production and control records were not prepared, according to the letter. And written procedures for production and process controls are inadequate.
- here's Warning Letter SEA 10-27