Company
GermanyDETAX GmbH & Co. KG, Ettlingen, Germany – FDA Inspections
Inspection records and compliance data for DETAX GmbH & Co. KG in Ettlingen. 1 FDA inspection on record, 1 Form 483, last inspected April 06, 2018.
Company Profile
This profile covers DETAX GmbH & Co. KG based in Ettlingen, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 6, 2018.
Most cited issue areas
- Design validation acceptance criteria1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DHR content1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1047145 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DETAX GmbH & Co. KG
FEI Number
1000293792
Address
Carl-Zeiss-Str. 4, Ettlingen, Germany
Country
Germany
ID: 0b21b841-e097-4684-9829-78be38a82594