Company
United StatesCarestream Health, Inc., Canandaigua, NY – FDA Inspections
Inspection records and compliance data for Carestream Health, Inc. in Canandaigua, New York. 2 FDA inspections on record, 1 Form 483, last inspected November 02, 2017.
Company Profile
This profile covers Carestream Health, Inc. based in Canandaigua, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 23, 2017. Last inspected November 2, 2017.
Most cited issue areas
- Design input - documentation1 inspection
- Documentation1 inspection
- Documentation - review in response to changes or deviations1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1031407 |
| March 23, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1006278 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Carestream Health, Inc.
FEI Number
3011681986
Address
5450 Campus Dr, Canandaigua, New York 14424, United States
Country
United States
ID: c04f601f-6e64-4e79-ae28-6ff9611c8ff8