Company
United StatesFujiFilm Healthcare Americas Corporation, Twinsburg, OH – FDA Inspections
Inspection records and compliance data for FujiFilm Healthcare Americas Corporation in Twinsburg, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected February 06, 2017.
Company Profile
This profile covers FujiFilm Healthcare Americas Corporation based in Twinsburg, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 4, 2009. Last inspected February 6, 2017.
Most cited issue areas
- Documentation2 inspections
- Report of Death or Serious Injury2 inspections
- Report of risk to health2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1000709 |
| April 8, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 824478 |
| February 1, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 640242 |
| August 4, 2009 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 605222 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FujiFilm Healthcare Americas Corporation
FEI Number
1528028
Address
1959 Summit Commerce Park, Twinsburg, Ohio 44087, United States
Country
United States
ID: 61802929-c43c-4a3a-8773-672bffc28e0c