998355
South Texas Botanicals — FEI 3010656208
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Beeville, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |