FDA Inspection
Control Micro Systems, Inc.Control Micro Systems, Inc. – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Control Micro Systems, Inc., with an inspection on September 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0328c58c-a542-4659-83ee-fb51223661a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067610
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
- 21 CFR 1002.30(a)(2)Basis for selecting methods, devices, procedures
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Other FDA inspections of Control Micro Systems, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2014 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 31, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 23, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Control Micro Systems, Inc.
- FDA Inspection 897813 - 2014-09-29
- FDA Inspection 765221 - 2012-01-31
- FDA Inspection 563271 - 2009-01-23
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