Company
AustriaHarps Europe Manufacturing, Wimpassing Im Schwarzatale, Austria – FDA Inspections
Inspection records and compliance data for Harps Europe Manufacturing in Wimpassing Im Schwarzatale. 1 FDA inspection on record, last inspected May 28, 2010.
Company Profile
This profile covers Harps Europe Manufacturing based in Wimpassing Im Schwarzatale, Austria.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected May 28, 2010.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- CAPA verification/validation of corrective/preventive action1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 28, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 669646 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Harps Europe Manufacturing
FEI Number
3007478974
Address
TRIESTER Bundesstrase 26, WIMPASSING NIEDEROSTERREICH, Wimpassing Im Schwarzatale, Austria
Country
Austria
ID: 2d8bb4fa-44b6-449d-89d8-09a187a1a8ec