FDA Inspection
Hyperbaric America LLCHyperbaric America LLC – FDA Inspection, Dec 2, 2009
Record Details
This FDA Inspection record concerns Hyperbaric America LLC, with an inspection on December 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hyperbaric America LLC
- Inspection Date
- December 2, 2009
- Product Type
- Devices
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ID · b653fa67-98c9-4f37-8a09-bae9470a1fd1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 632590
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(c)Design input procedures - appropriateness
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.181(c)DMR QA procedures and specifications
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Other FDA inspections of Hyperbaric America LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hyperbaric America LLC
- FDA Inspection 615796 - 2009-09-28
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