FDA Inspection 1004170 — ECUAFISH S.A.
The FDA completed an inspection of ECUAFISH S.A. on Nov 8, 2016 in ESMERALDAS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 8, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- ESMERALDAS (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |