Company
GermanyASSKEA GmbH, Gebesee, Germany – FDA Inspections
Inspection records and compliance data for ASSKEA GmbH in Gebesee. 1 FDA inspection on record, 1 Form 483, last inspected November 17, 2017.
Company Profile
This profile covers ASSKEA GmbH based in Gebesee, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 17, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1032109 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ASSKEA GmbH
FEI Number
3013857114
Address
Haslocher Str. 9, Gebesee, Germany
Country
Germany
ID: 728e51b2-d1c2-47eb-9f19-63dedb463c81