FDA Inspection
Drake Precision Dental LaboratoryDrake Precision Dental Laboratory – FDA Inspection, Nov 5, 2025
Record Details
This FDA Inspection record concerns Drake Precision Dental Laboratory, with an inspection on November 5, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
- Inspection Date
- November 5, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 1d813874-f91b-4983-98c6-2784ea22a3df
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1290296
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Drake Precision Dental Laboratory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Drake Precision Dental Laboratory
- FDA Inspection 1109972 - 2019-11-14
- FDA Inspection 1014169 - 2017-03-27
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