FDA Inspection
Maquet Medical Systems USAFDA Inspection 851698 - Maquet Medical Systems USA - October 15, 2013
Record Details
This FDA Inspection record concerns Maquet Medical Systems USA, with an inspection on October 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maquet Medical Systems USA
- Inspection Date
- October 15, 2013
- Product Type
- Devices
View Company Profile
ID · 4a30055e-d63b-496e-9254-cf556ff34c07
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851698
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 806.10(c)(8)Illness report
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate 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 803.40(a)Report of death, injury
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Other FDA inspections of Maquet Medical Systems USA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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