FDA Inspection
DORO INC ( O/S DORO SAFETY & SECURITY)DORO INC ( O/S DORO SAFETY & SECURITY) – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns DORO INC ( O/S DORO SAFETY & SECURITY), with an inspection on February 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 2, 2023
- Product Type
- Devices
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ID · b2c0f7cf-d333-4c16-90a6-798d5bdaa167
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196715
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DORO INC ( O/S DORO SAFETY & SECURITY)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 13, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DORO INC ( O/S DORO SAFETY & SECURITY)
- FDA Inspection 1109664 - 2019-11-13
- FDA Inspection 951670 - 2015-11-05
- FDA Inspection 904198 - 2014-11-13
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