# FDA WARNING_LETTER - Oxysure Systems, Inc. - October 03, 2014

Source: https://www.keypedia.com/records/warning_letter/oxysure-systems-inc/f1f1fb13-d96d-4d2b-8c96-912bf87a1b57

> FDA WARNING_LETTER for Oxysure Systems, Inc. on October 03, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Oxysure Systems, Inc.
- Inspection Date: 2014-10-03
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.keypedia.com/companies/oxysure-systems-inc/a8b0f299-d8db-4e76-b55b-e86badc16237

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9