Company
United StatesFUJIFILM Healthcare Americas Corporation, Lexington, MA – FDA Inspections
Inspection records and compliance data for FUJIFILM Healthcare Americas Corporation in Lexington, Massachusetts. 6 FDA inspections on record, 2 Form 483s, last inspected June 21, 2019.
Company Profile
This profile covers FUJIFILM Healthcare Americas Corporation based in Lexington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected December 12, 2012. Last inspected June 21, 2019.
Most cited issue areas
- Failure to report1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 21, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1095860 |
| March 29, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1046796 |
| November 10, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 994698 |
| October 31, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 991423 |
| February 19, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 919044 |
| December 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 810738 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FUJIFILM Healthcare Americas Corporation
FEI Number
1000513161
Address
81 Hartwell Ave Ste 300, Lexington, Massachusetts 02421, United States
Country
United States
ID: 2125ef05-abe1-4bb0-953b-31cb8254e1e8