FDA Inspection
Crane Dental Laboratory, Inc.Crane Dental Laboratory, Inc. – FDA Inspection, Dec 18, 2018
Record Details
This FDA Inspection record concerns Crane Dental Laboratory, Inc., with an inspection on December 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cd2c6363-aa5c-4432-898b-7224158bb041
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075217
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Crane Dental Laboratory, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| September 1, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Crane Dental Laboratory, Inc.
- FDA Inspection 1277490 - 2025-08-05
- FDA Inspection 1179105 - 2022-09-01
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