Department Of Defense - Navy (U.S. Naval Hospital Sigonella) — FDA Facility Profile
Department Of Defense - Navy (U.S. Naval Hospital Sigonella) is an FDA-inspected facility (FEI 3002808608) located in Sigonella, IT. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 18, 2025: No Action Indicated (NAI)
- Inspections on record
- 8 (3 VAI, 5 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 18, 2025 | No Action Indicated (NAI) | No citations listed |
| Jul 18, 2023 | No Action Indicated (NAI) | No citations listed |
| May 3, 2019 | No Action Indicated (NAI) | No citations listed |
| May 10, 2017 | Voluntary Action Indicated (VAI) | Collection/initial processing facility labels (21 CFR 606.121(b)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| Jun 11, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 4, 2013 | Voluntary Action Indicated (VAI) | Maintain and clean equipment (21 CFR 606.60(a)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Thorough investigations (21 CFR 606.100(c)) |
| Jun 21, 2011 | Voluntary Action Indicated (VAI) | Changes to Procedures Not Reviewed, Approved (21 CFR 211.100(a)) Procedure Deviations Recorded and Justified (21 CFR 211.100(b)) Schedules and procedures for equipment & calibration (21 CFR 606.100(b)(15)) |
| Jun 11, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Department Of Defense - Navy (U.S. Naval Hospital Sigonella)
- Location
- Sigonella (IT)
- Source
- inspections