Blue Shell S.A. — FDA Facility Profile
Blue Shell S.A. is an FDA-inspected facility (FEI 3013273137) located in Dalcahue, CL. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 6, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 6, 2022 | Voluntary Action Indicated (VAI) | Monitoring - adequacy (21 CFR 123.6(c)(4)) Verification procedures - none/frequency (21 CFR 123.6(c)(6)) |
| Aug 11, 2017 | Voluntary Action Indicated (VAI) | Sanitation monitoring (21 CFR 123.11(b)) Verification procedures - none/frequency (21 CFR 123.6(c)(6)) Records - content (21 CFR 123.9(a)) |
Facility details
- Company
- Blue Shell S.A.
- Location
- Dalcahue (CL)
- Source
- inspections