Company
GermanySTERIS Deutschland GmbH, Tuttlingen, Germany – FDA Inspections
Inspection records and compliance data for STERIS Deutschland GmbH in Tuttlingen. 2 FDA inspections on record, 1 Form 483, last inspected November 04, 2022.
Company Profile
This profile covers STERIS Deutschland GmbH based in Tuttlingen, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected February 8, 2018. Last inspected November 4, 2022.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 4, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1193160 |
| February 8, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1040278 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
STERIS Deutschland GmbH
FEI Number
1000482681
Address
Sattlerstr. 25, Tuttlingen, Germany
Country
Germany
ID: c601bd47-c5a3-4270-bf64-c6cd4c239fea