Company
GermanyHIDREX GmbH, Heiligenhaus, Germany – FDA Inspections
Inspection records and compliance data for HIDREX GmbH in Heiligenhaus. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 09, 2023.
Company Profile
This profile covers HIDREX GmbH based in Heiligenhaus, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 26, 2017. Last inspected November 9, 2023.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Investigation of device failures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1222347 |
| January 26, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1002806 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HIDREX GmbH
FEI Number
3008642982
Address
Otto-Hahn-Str. 12, Heiligenhaus, Germany
Country
Germany
ID: eeb8238b-2324-4f56-bf8c-600717ff2e64