FDA Inspection 661066 — Pesnusan Cia Ltda
The FDA completed an inspection of Pesnusan Cia Ltda on May 11, 2010 in Manta. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 11, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Manta (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 931 | 21 CFR 123.8(d) | Verification - recordkeeping |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |