FDA Inspection
Dalton Medical CorpDalton Medical Corp – FDA Inspection, Jan 22, 2024
Record Details
This FDA Inspection record concerns Dalton Medical Corp, with an inspection on January 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fe76c2c7-c101-417d-b500-1b6b17221b02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
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Other FDA inspections of Dalton Medical Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dalton Medical Corp
- FDA Inspection 1179558 - 2022-09-15
- FDA Inspection 1062473 - 2018-07-10
- FDA Inspection 701692 - 2010-12-13
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