FRANZESE S.P.A. — FDA Facility Profile
FRANZESE S.P.A. is an FDA-inspected facility (FEI 3004329625) located in Palma Campania, IT. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Oct 30, 2018: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Nov 5, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 30, 2014
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 30, 2018 | Voluntary Action Indicated (VAI) | Entry not made (21 CFR 113.100(b)) Initial temperature: cans in water filled retorts (21 CFR 113.87(c)) Records of process establishment (21 CFR 113.83) Process change - increase (21 CFR 108.35(c)(2)(ii)) and 1 more |
| Nov 5, 2013 | Official Action Indicated (OAI) | No accurate TID (21 CFR 113.40(b)(1)) Initial temperature: cans in water filled retorts (21 CFR 113.87(c)) Process deviation identification (21 CFR 113.89) Process adherence (21 CFR 108.35(c)(3)(i)) |
Facility details
- Company
- FRANZESE LA PALMA SRL
- Location
- Palma Campania (IT)
- Source
- inspections