FDA Inspection 1019345 — PT Guna Citra Kartika
The FDA completed an inspection of PT Guna Citra Kartika on May 23, 2017 in Jepara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Jepara (Indonesia)
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 |
| 929 | 21 CFR 123.8(b) | Verification - corrective action |
| 932 | 21 CFR 123.7(d) | Corrective action documentation |
| 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 |