FDA Inspection
Gulf Coast Hyperbarics, Inc.Gulf Coast Hyperbarics, Inc. – FDA Inspection, Sep 12, 2013
Record Details
This FDA Inspection record concerns Gulf Coast Hyperbarics, Inc., with an inspection on September 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gulf Coast Hyperbarics, Inc.
- Inspection Date
- September 12, 2013
- Product Type
- Devices
View Company Profile
ID · d3e58c8d-f405-4ecb-ad40-2352bc57a61e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848644
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17(b)(2)Reports and information documentation
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