Company
GermanyELCAT GmbH, Wolfratshausen, Germany – FDA Inspections
Inspection records and compliance data for ELCAT GmbH in Wolfratshausen. 1 FDA inspection on record, 1 Form 483, last inspected January 31, 2019.
Company Profile
This profile covers ELCAT GmbH based in Wolfratshausen, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected January 31, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 31, 2019 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1077644 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ELCAT GmbH
FEI Number
3001264992
Address
Burgermeister-Finsterwalder-Ring 27, Wolfratshausen, Germany
Country
Germany
ID: fb0350b8-2ba0-40cb-8d62-f3feb9df2493