Company
AustriaDr. Gernot Schuhfried Ges.m.b.H., Modling, Austria – FDA Inspections
Inspection records and compliance data for Dr. Gernot Schuhfried Ges.m.b.H. in Modling. 1 FDA inspection on record, 1 Form 483, last inspected May 18, 2017.
Company Profile
This profile covers Dr. Gernot Schuhfried Ges.m.b.H. based in Modling, Austria.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 18, 2017.
Most cited issue areas
- Design validation - software validation documentation1 inspection
- Design verification - output does not meet input requirement1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1018320 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dr. Gernot Schuhfried Ges.m.b.H.
FEI Number
3005345740
Address
Hyrtlstrase 45, Modling, Austria
Country
Austria
ID: c24dfba1-1923-4426-9697-2ce2956461d1