FDA Inspection 1072344 — Advanced Botanical Consulting & Testing, LLC
The FDA completed an inspection of Advanced Botanical Consulting & Testing, LLC on November 13, 2018 in Tustin, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 13, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |