FDA Inspection
Seven Oaks Ranch IncSeven Oaks Ranch Inc – FDA Inspection, Dec 7, 2012
Record Details
This FDA Inspection record concerns Seven Oaks Ranch Inc, with an inspection on December 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Seven Oaks Ranch Inc
- Inspection Date
- December 7, 2012
- Product Type
- Devices
View Company Profile
ID · 91aa9218-0730-4ad7-83c2-cf685605acaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809060
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Seven Oaks Ranch Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2025 | Not classified | Los Angeles District Office | |
| December 2, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 29, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Seven Oaks Ranch Inc
- FDA Inspection 1276765 - 2025-06-13
- FDA Inspection 1262762 - 2025-02-11
- FDA Inspection 1159436 - 2021-12-02
- FDA Inspection 1071868 - 2018-11-14
- FDA Inspection 1068759 - 2018-08-29
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