FDA Inspection 1077306 — PT. Primo Indo Ikan
The FDA completed an inspection of PT. Primo Indo Ikan on January 22, 2019 in Denpasar. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 22, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denpasar (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 18143 | 21 CFR 117.35(b)(1) | Cleaning and sanitizing substances - Safe and adequate |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |