FDA WARNING_LETTER - Gooten Innolife Corp - March 08, 2012

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