FDA Inspection
Dolor Technologies LLCDolor Technologies LLC – FDA Inspection, Apr 17, 2017
Record Details
This FDA Inspection record concerns Dolor Technologies LLC, with an inspection on April 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e4ba135c-823c-41be-8965-c46634de4480
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1008362
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of Dolor Technologies LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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