FDA Inspection 1109655 — CA BOTANA International, Inc.
The FDA completed an inspection of CA BOTANA International, Inc. on November 12, 2019 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2019
- Fiscal Year
- 2020
- 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 |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |