Company
GermanyIRT Systems GmbH, Koblenz, Germany – FDA Inspections
Inspection records and compliance data for IRT Systems GmbH in Koblenz. 1 FDA inspection on record, 1 Form 483, last inspected June 16, 2017.
Company Profile
This profile covers IRT Systems GmbH based in Koblenz, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected June 16, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 16, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1020729 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
IRT Systems GmbH
FEI Number
3010875109
Address
Schlosstr. 1, Koblenz, Germany
Country
Germany
ID: 581bce35-1647-43fa-9040-8bb95ef137e3