FDA Inspection 1265869 — CA BOTANA International, Inc.
The FDA completed an inspection of CA BOTANA International, Inc. on Apr 4, 2025 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |