FDA Inspection 1223908 — Aura Cacia
The FDA completed an inspection of Aura Cacia on Dec 1, 2023 in Urbana, IA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 1, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Urbana, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |