FDA Inspection
STERIS Deutschland GmbHSTERIS Deutschland GmbH – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns STERIS Deutschland GmbH, with an inspection on February 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1b4a06dd-cebc-43b0-ac7a-02df0ec3e984
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040278
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of STERIS Deutschland GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for STERIS Deutschland GmbH
- FDA Inspection 1193160 - 2022-11-04
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