Santanello Surgical LLC — FDA Facility Profile
Santanello Surgical LLC is an FDA-inspected facility (FEI 3013555389) located in Columbus, OH, US. RegDataLab tracks 1 FDA inspection at this facility.
Reviewing Santanello Surgical LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Santanello Surgical LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Jun 7, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- 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 Jun 10, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 7, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design control - no procedures (21 CFR 820.30(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate DHR procedures (21 CFR 820.184) and 4 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 10, 2019 | Not yet classified | Z-2237-2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to… Lack of package integrity may compromise sterility |
Facility details
- Company
- Santanello Surgical LLC
- Location
- Columbus, OH (US)
- Source
- inspections