FDA Inspection
Carestream Health, Inc.Carestream Health, Inc. – FDA Inspection, Aug 15, 2018
Record Details
This FDA Inspection record concerns Carestream Health, Inc., with an inspection on August 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 21a82d5f-7a14-4b2d-bb3b-a74b5f9f6c70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063729
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Carestream Health, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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