# FDA WARNING_LETTER - Ogenix Corporation - March 01, 2012

Source: https://www.keypedia.com/records/warning_letter/ogenix-corporation/313cd07a-160a-41db-a2a0-d3fdf4a7bbd3

> FDA WARNING_LETTER for Ogenix Corporation on March 01, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ogenix Corporation
- Inspection Date: 2012-03-01
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On March 27, 2012, the FDA issued a Warning Letter to Ogenix Corporation following an inspection from February 13 to March 1, 2012, at their Beachwood, Ohio facility. The inspection determined Ogenix is a specification developer for the EpiFLO topical oxygen system, classified as a device under 21 U.S.C. § 321(h). The devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 C.F.R. Part 820).

Violations included:
1.  Failure to establish and maintain procedures for purchased products and services (21 C.F.R. § 820.50), specifically not implementing the "Supplier Management Procedure" for critical suppliers and not including the membrane electrode assembly supplier on the approved list.
2.  Failure to validate new EpiFLO designs (7-Day and 15-Day devices released August 2006) to ensure conformity to user/patient needs (21 C.F.R. § 820.30(g)).
3.  Failure to adequately establish design inputs for device requirements, including strength and durability for devices worn 24/7,

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)
- [Director of Compliance Branch](https://www.keypedia.com/people/gina-brackett/fa52f03a-8a7e-485e-8773-a1da3fa628d7)

Company: https://www.keypedia.com/companies/ogenix-corporation/11009063-f17f-4668-bd1e-a3aa3e543aad

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861