FDA Inspection 1247853 — Riclan S.A.
The FDA completed an inspection of Riclan S.A. on Aug 13, 2024 in Rio Claro. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 13, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Rio Claro (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 15515 | 21 CFR 111.27(d)(3) | Contact surfaces - continuous operation - clean |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |