FDA Inspection
HYPERBARIC MODULAR SYSTEMS, INC.HYPERBARIC MODULAR SYSTEMS, INC. – FDA Inspection, Nov 24, 2008
Record Details
This FDA Inspection record concerns HYPERBARIC MODULAR SYSTEMS, INC., with an inspection on November 24, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 24, 2008
- Product Type
- Devices
View Company Profile
ID · 68af364b-40a2-4074-9c9d-6e69c3054ae2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547738
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(c)Management review accomplishment
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HYPERBARIC MODULAR SYSTEMS, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for HYPERBARIC MODULAR SYSTEMS, INC.
- FDA Inspection 841744 - 2013-07-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.