1117031
BioMylz Pvt. Ltd. — FEI 3013697420
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |