Company
United StatesCarestream Health, Inc., Rochester, NY – FDA Inspections
Inspection records and compliance data for Carestream Health, Inc. in Rochester, New York. 2 FDA inspections on record, 1 Form 483, last inspected August 15, 2018.
Company Profile
This profile covers Carestream Health, Inc. based in Rochester, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 3, 2008. Last inspected August 15, 2018.
Most cited issue areas
- Documentation1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1063729 |
| October 3, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 541483 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Carestream Health, Inc.
FEI Number
1317267
Address
1669 Lake Avenue, Rochester, New York 14652, United States
Country
United States
ID: c363f903-eebc-41f2-9699-fc52ac132d21