FDA Inspection
CM Instrumente GmbHCM Instrumente GmbH – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns CM Instrumente GmbH, with an inspection on August 30, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d836a1da-28ee-4056-9af0-dc17026ee869
Inspection Facts
- Inspection number
- 1064784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of CM Instrumente GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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