SOFRADIM PRODUCTION FDA Inspection Record
SOFRADIM PRODUCTION is an FDA-registered facility (FEI 3003521774) located in TREVOUX Auvergne-Rhone-Alpes, FR. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Mar 19, 2015: No Action Indicated (NAI)
- Inspections on record
- 3 (1 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Feb 23, 2018
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 19, 2015 | No Action Indicated (NAI) | No citations listed |
| Nov 7, 2011 | Voluntary Action Indicated (VAI) | Periodic equipment inspections (21 CFR 820.70(g)(2)) |
| Jan 22, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 23, 2018 | Class II | Z-1523-2018 | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M
The device is made out of a… There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the… |
Facility details
- Company
- Sofradim Production
- Location
- TREVOUX Auvergne-Rhone-Alpes (FR)
- Source
- device