1030939
TRUECARE BIOMEDIX — FEI 3010166683
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 3, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Balasinor (India)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3608 | 21 CFR 211.160(b)(2) | Sampling/testing of in-process materials |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |