Company
GermanyAMTRION GMBH (Formerly Haseke & Kroemker), Porta Westfalica, Germany – FDA Inspections
Inspection records and compliance data for AMTRION GMBH (Formerly Haseke & Kroemker) in Porta Westfalica. 2 FDA inspections on record, 1 Form 483, last inspected April 06, 2018.
Company Profile
This profile covers AMTRION GMBH (Formerly Haseke & Kroemker) based in Porta Westfalica, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 11, 2014. Last inspected April 6, 2018.
Most cited issue areas
- Design review - documentation1 inspection
- DMR - not or inadequately maintained1 inspection
- Lack of or inadequate organizational structure1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1047120 |
| December 11, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 906511 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AMTRION GMBH (Formerly Haseke & Kroemker)
FEI Number
3005285078
Address
Sandtrift 1, Porta Westfalica, Germany
Country
Germany
ID: 1d1c2d18-9300-4cee-a0bc-75d988ed5bcd