FDA Inspection
Orthodent Laboratory, Inc.Orthodent Laboratory, Inc. – FDA Inspection, Nov 13, 2023
Record Details
This FDA Inspection record concerns Orthodent Laboratory, Inc., with an inspection on November 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89255fb1-7f40-4f81-bcc9-e523a705f75f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1223196
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of Orthodent Laboratory, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Orthodent Laboratory, Inc.
- FDA Inspection 1137122 - 2021-03-24
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