FDA Inspection
Dalton Medical CorpDalton Medical Corp – FDA Inspection, Sep 15, 2022
Record Details
This FDA Inspection record concerns Dalton Medical Corp, with an inspection on September 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dalton Medical Corp
- Inspection Date
- September 15, 2022
- Product Type
- Devices
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ID · d85cb60f-95fb-411b-9143-ce47730aea0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179558
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.200(d)Service reports
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dalton Medical Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2024 | 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 1228542 - 2024-01-22
- FDA Inspection 1062473 - 2018-07-10
- FDA Inspection 701692 - 2010-12-13
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