FDA Inspection 940323 — PERUSAHAAN KERUPUK KOMODO
The FDA completed an inspection of PERUSAHAAN KERUPUK KOMODO on September 1, 2015 in Sidoarjo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Sidoarjo (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 1696 | 21 CFR 110.80(b)(3) | Holding foods - refrigerate/freeze/heat |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6021 | 21 CFR 123.10 | HACCP training or qualification |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 913 | 21 CFR 123.8(a)(1) | Reassessment of HACCP plan |
| 931 | 21 CFR 123.8(d) | Verification - recordkeeping |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |