FDA Inspection
Dot InternationalDot International – FDA Inspection, Feb 26, 2019
Record Details
This FDA Inspection record concerns Dot International, with an inspection on February 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Emma R. Schaefer (Issuing Officer)
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ID · d4ef1a7c-1f63-44df-90e0-f640a212a7ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082434
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Dot International
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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