FDA Inspection 977316 — PT Bandar Nelayan
The FDA completed an inspection of PT Bandar Nelayan on May 17, 2016 in Denpasar. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 17, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denpasar (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 932 | 21 CFR 123.7(d) | Corrective action documentation |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 975 | 21 CFR 123.9(b)(1) | Record retention |