FENWAL INTERNATIONAL, INC. FDA Inspection Record
FENWAL INTERNATIONAL, INC. is an FDA-registered facility (FEI 3002806457) located in HAINA San Cristobal, DO. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 25, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (1 VAI, 2 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
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 25, 2023 | Voluntary Action Indicated (VAI) | Buildings (21 CFR 820.70(f)) Equipment design and installation (21 CFR 820.70(g)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Nonconforming product control (21 CFR 820.90(a)) and 3 more |
| Nov 15, 2019 | No Action Indicated (NAI) | No citations listed |
| Sep 29, 2016 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Fenwal International, Inc.
- Location
- HAINA San Cristobal (DO)
- Source
- device