Oxysure Systems, Inc. – FDA Warning Letter, Oct 3, 2014

On September 3-October 3, 2014, an FDA inspection of OxySure Systems, Inc. in Frisco, Texas, revealed that their OxySure portable oxygen generator is an adulterated device under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Nonconforming Product Control (21 CFR 820.90(a)):** Failure to identify, control, evaluate, and disposition OxySure canisters that did not meet the 6 LPM for 15 minutes oxygen flow rate specification. Distributed nonconforming lots without investigation. 2. **Acceptance Activities (21 CFR 820.80):** Inadequate procedures for receiving and finished product acceptance, including lack of documented evaluation for flow rate tests, undocumented pressure relief valve testing, and undocumented leak test results. 3. **Design Changes (21 CFR 820.30(i)):** Failure to establish and maintain procedures for design changes, with incomplete Engineering Change Notices (ECNs) and insufficient verification testing data for design modifications. 4. **Process Validation (21 CFR 820.75(a)):** Lack of validation for critical processes, including an in-house leak test method, bonding processes, and heat treatment processes.