Nitrox, Inc. – FDA Warning Letter, Apr 19, 2010

During an FDA inspection from March 22 to April 19, 2010, of a manufacturing facility in Lynnwood, Washington, significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) were identified, rendering drug products adulterated.

Key violations include: 1. **Lack of Finished Product Testing:** No laboratory determination of conformance to final specifications for Dolonox (50% USP Nitrous Oxide and 50% USP Oxygen) prior to release, with (b)(4) cylinders released untested from 2003-2009 (21 CFR § 211.165(a)). 2. **Inadequate Specifications and Test Procedures:** No scientifically sound procedures for testing liquid Nitrogen NF for assay and oxygen limit; the "Splitter Test" for identity is unsound, and (b)(4) handheld analyzers for assay are unvalidated (21 CFR § 211.160(b)). 3. **Missing Batch Production Records:** No batch production and control records for Dolonox, lacking documentation of prefill checks like visual examination, dead ring tests, odor checks, and vacuum evacuation (21 CFR § 211.188(b)). 4. **Absence of Written Procedures:** No adequate written procedures for manufacturing, testing, and distribution