FDA Inspection
Maquet Medical Systems USAFDA Inspection 994818 - Maquet Medical Systems USA - September 29, 2016
Record Details
This FDA Inspection record concerns Maquet Medical Systems USA, with an inspection on September 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maquet Medical Systems USA
- Inspection Date
- September 29, 2016
- Product Type
- Devices
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ID · d0531410-9f89-44ff-8450-ae5a56a0daaf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 994818
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)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
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Maquet Medical Systems USA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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