FDA Inspection 1136796 — Advanced Botanical Consulting & Testing, LLC
The FDA completed an inspection of Advanced Botanical Consulting & Testing, LLC on March 15, 2021 in Tustin, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 3606 | 21 CFR 211.160(b)(1) | Retesting |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |