FDA Inspection 1095228 — PT Dempo Andalas Samudera
The FDA completed an inspection of PT Dempo Andalas Samudera on Jun 21, 2019 in Padang. 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Padang (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 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 |