Stephanix — FDA Facility Profile
Stephanix is an FDA-registered facility (FEI 3006972752) located in La Ricamarie Auvergne-Rhone-Alpes, FR. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 14, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Aug 12, 2016
- Recalls as the recalling firm
- 1, latest Nov 2, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 14, 2023 | Voluntary Action Indicated (VAI) | Design plans - Lack of or inadequate (21 CFR 820.30(b)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 2, 2018 | Not yet classified | Z-0557-2019 | STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/tr… The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of… |
Facility details
- Company
- Stephanix
- Location
- La Ricamarie Auvergne-Rhone-Alpes (FR)
- Source
- device