Company
United StatesCAPTEK, Inc., Berwyn, PA – FDA Inspections
Inspection records and compliance data for CAPTEK, Inc. in Berwyn, Pennsylvania. 1 FDA inspection on record, last inspected September 25, 2009.
Company Profile
This profile covers CAPTEK, Inc. based in Berwyn, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 25, 2009.
Most cited issue areas
- Design changes - validation vs. verification1 inspection
- Design history file1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 614651 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CAPTEK, Inc.
FEI Number
2523071
Address
1043 Lancaster Ave, Berwyn, Pennsylvania 19312, United States
Country
United States
ID: 9a8222e1-92ac-45b4-a5b8-24b3994cfc0e