FDA Inspection
Carestream Health, Inc.Carestream Health, Inc. – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Carestream Health, Inc., with an inspection on March 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f615c540-606f-4ece-8a10-c5dad725cd12
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1006278
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of Carestream Health, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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