Company
United StatesAGFA Healthcare Corporation, Canton, MA – FDA Inspections
Inspection records and compliance data for AGFA Healthcare Corporation in Canton, Massachusetts. 3 FDA inspections on record (1 OAI), last inspected September 29, 2016.
Company Profile
This profile covers AGFA Healthcare Corporation based in Canton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected January 6, 2011. Last inspected September 29, 2016.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Analyzing service report1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 29, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 988464 |
| November 4, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 749180 |
| January 6, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 705822 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AGFA Healthcare Corporation
FEI Number
3000204644
Address
150 Royall St, Canton, Massachusetts 02021, United States
Country
United States
ID: 5707333c-c23e-4338-99fd-7bc6fb43bf93