FDA Inspection 1090175 — PT. Gunacipta Multirasa
The FDA completed an inspection of PT. Gunacipta Multirasa on May 21, 2019 in Tangerang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tangerang (Indonesia)
Citations
| ID | CFR | Description |
|---|---|---|
| 3067 | 21 CFR 114.80(a) | Quality control procedures |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |