FDA Inspection 1061738 — Comdalgel
The FDA completed an inspection of Comdalgel on Jul 24, 2018 in Vagos. 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
- Jul 24, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Vagos (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6021 | 21 CFR 123.10 | HACCP training or qualification |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |