FDA Inspection 773950 — PT. Windika Utama
The FDA completed an inspection of PT. Windika Utama on Mar 23, 2012 in Semarang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Semarang (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 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 |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 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 |