FDA Inspection 1028369 — South Texas Botanicals
The FDA completed an inspection of South Texas Botanicals on October 6, 2017 in Beeville, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 6, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Beeville, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |