FDA Inspection
YSI IncorporatedYSI Incorporated – FDA Inspection, Mar 9, 2011
Record Details
This FDA Inspection record concerns YSI Incorporated, with an inspection on March 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- YSI Incorporated
- Inspection Date
- March 9, 2011
- Product Type
- Devices
View Company Profile
ID · 38150a36-f1d9-49eb-8c16-0828fc3103c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718461
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance 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 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of YSI Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2026 | Not classified | Cincinnati District Office | |
| August 22, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for YSI Incorporated
- FDA Inspection 1315782 - 2026-04-30
- FDA Inspection 1216345 - 2023-08-22
- FDA Inspection 871932 - 2014-03-27
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