FDA Inspection
Adapta Medical, Inc.Adapta Medical, Inc. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Adapta Medical, Inc., with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Adapta Medical, Inc.
- Inspection Date
- January 26, 2012
- Product Type
- Devices
View Company Profile
ID · 95a8b073-7c33-4ec9-856c-a6fa27691598
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765250
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Adapta Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Adapta Medical, Inc.
- FDA Inspection 953637 - 2015-12-02
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