FDA Inspection 1178036 — Soterion Development, Inc.
The FDA completed an inspection of Soterion Development, Inc. on Aug 23, 2022 in David. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- David (Panama)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |