Pancrazio S.P.A. — FDA Facility Profile
Pancrazio S.P.A. is an FDA-inspected facility (FEI 3004684819) located in Cava De' Tirreni, 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
- Sep 9, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Oct 31, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 18, 2014
- Import refusals
- 9
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 9, 2022 | Voluntary Action Indicated (VAI) | Recording device records - dated; retort number (21 CFR 113.100(b)) Process adherence (21 CFR 108.35(c)(3)(i)) |
| Oct 31, 2013 | Official Action Indicated (OAI) | Scheduled process - scientific methods not used (21 CFR 113.83) Review not timely (21 CFR 113.100(b)) Process deviation identification (21 CFR 113.89) Process filing (21 CFR 108.35(c)(2)) and 1 more |
Facility details
- Company
- Pancrazio S.P.A.
- Location
- Cava De' Tirreni (IT)
- Source
- inspections