FDA Inspection
Mibo Medical GroupMibo Medical Group – FDA Inspection, May 10, 2018
Record Details
This FDA Inspection record concerns Mibo Medical Group, with an inspection on May 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d13d5cc9-dfef-4f80-880e-6711c445915e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1051389
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - 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 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mibo Medical Group
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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