FDA Inspection
Dot InternationalDot International – FDA Inspection, Mar 5, 2020
Record Details
This FDA Inspection record concerns Dot International, with an inspection on March 5, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dot International
- Inspection Date
- March 5, 2020
- Product Type
- Devices
View Company Profile
ID · b274a8c3-e98a-4db9-bcd3-145a6c21cae2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1120462
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.184(f)DHR - UDI not included
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Other FDA inspections of Dot International
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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