Company
United StatesAgfa Healthcare Corporation, Carlstadt, NJ – FDA Inspections
Inspection records and compliance data for Agfa Healthcare Corporation in Carlstadt, New Jersey. 2 FDA inspections on record, last inspected March 29, 2013.
Company Profile
This profile covers Agfa Healthcare Corporation based in Carlstadt, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 4, 2010. Last inspected March 29, 2013.
Most cited issue areas
- Adverse events--all info not in file1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 824872 |
| May 4, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 661434 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Agfa Healthcare Corporation
FEI Number
1000322596
Address
580 Gotham Pkwy, Carlstadt, New Jersey 07072, United States
Country
United States
ID: 7cf45d75-9bcb-4df4-8b54-d526f1f37d3a