EMPACADORA DIAMANTE — FDA Facility Profile
EMPACADORA DIAMANTE is an FDA-inspected facility (FEI 3006383566) located in ESMERALDAS, EC. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Feb 23, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 OAI, 1 VAI)
- Last OAI inspection
- Apr 4, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 23, 2013
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 23, 2016 | Voluntary Action Indicated (VAI) | Verification - record review - frequency (21 CFR 123.8(a)(3)) HACCP plan implementation (21 CFR 123.6(b)) Verification - recordkeeping (21 CFR 123.8(d)) |
| Apr 4, 2013 | Official Action Indicated (OAI) | No citations listed |
| Mar 31, 2009 | Official Action Indicated (OAI) | Metal / extraneous materials (21 CFR 110.80(b)(8)) Monitoring - adequacy (21 CFR 123.6(c)(4)) Verification procedures - none/frequency (21 CFR 123.6(c)(6)) Records - content (21 CFR 123.9(a)) and 5 more |
Facility details
- Company
- EMPACADORA DIAMANTE
- Location
- ESMERALDAS (EC)
- Source
- inspections