FDA Inspection
SimproFDA Inspection 1065486 - Simpro - September 13, 2018
Record Details
This FDA Inspection record concerns Simpro, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Simpro
- Inspection Date
- September 13, 2018
- Product Type
- Devices
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ID · ed482aee-0a9c-4a4e-b863-bb487e16fa98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065486
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Simpro
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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