FDA Inspection 573128 — EMPACADORA DIAMANTE
The FDA completed an inspection of EMPACADORA DIAMANTE on March 31, 2009 in ESMERALDAS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- ESMERALDAS (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1702 | 21 CFR 110.80(b)(8) | Metal / extraneous materials |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6015 | 21 CFR 123.6(c)(6) | Verification procedures - none/frequency |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |