ALFASIGMA SPA — FDA Facility Profile
ALFASIGMA SPA is an FDA-registered facility (FEI 3002808171) located in Rome, IT. Registered operations: MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jan 26, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (5 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
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 26, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| May 28, 2021 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 21, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 10, 2015 | Voluntary Action Indicated (VAI) | Clothing appropriate for duties performed (21 CFR 211.28(a)) Absence of Written Procedures (21 CFR 211.100(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Procedures for non-sterile drug products (21 CFR 211.113(a)) and 3 more |
| Sep 16, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Alfasigma S.P.A.
- Location
- Rome (IT)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- decrs