FDA Inspection
DORO INC ( O/S DORO SAFETY & SECURITY)DORO INC ( O/S DORO SAFETY & SECURITY) – FDA Inspection, Nov 13, 2014
Record Details
This FDA Inspection record concerns DORO INC ( O/S DORO SAFETY & SECURITY), with an inspection on November 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 13, 2014
- Product Type
- Devices
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ID · 7dd3bcfd-23bc-4045-95fc-5951d2971b54
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 904198
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of DORO INC ( O/S DORO SAFETY & SECURITY)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for DORO INC ( O/S DORO SAFETY & SECURITY)
- FDA Inspection 1196715 - 2023-02-02
- FDA Inspection 1109664 - 2019-11-13
- FDA Inspection 951670 - 2015-11-05
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