# FDA WARNING_LETTER - Gooten Innolife Corp - March 08, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/gooten-innolife-corp/6070e222-5605-4776-8b8e-fbd08af8d1fe

> FDA WARNING_LETTER for Gooten Innolife Corp on March 08, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Gooten Innolife Corp
- Inspection Date: 2012-03-08
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On July 16, 2012, the FDA issued a Warning Letter to Gooten Innolife Corporation following an inspection from March 5-8, 2012, which identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for their contract-manufactured HairMax Laser Comb and manufactured Oxygen Bar devices.

Key violations include:
1.  **Design Control (21 CFR 820.30(a))**: Failure to establish and maintain adequate design control procedures, specifically QP-0401 Document Control, which was not implemented during the Oxygen Bar design project.
2.  **Design Plans (21 CFR 820.30(b))**: Inadequate design plans for the Oxygen Bar, lacking details on design stages, group interfaces, and updates as the design evolved.
3.  **Design Verification (21 CFR 820.30(f))**: Procedures for verifying device design (PR-0701) did not address design verification, lacking documentation that design outputs met input requirements for the oxygen concentrator.
4.  **Design Validation (21 CFR 820.30(g))**: Procedures for validating device design (PR-0701) were inadequate, lacking validation study protocols, pre-approved acceptance criteria, proper documentation of test methods/results, and use of

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/gooten-innolife-corp/9e06c8bf-4658-491c-a347-d3e8d9f78830

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