FDA Inspection 1033847 — Health Biotech Limited
The FDA completed an inspection of Health Biotech Limited on December 5, 2017 in Baddi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 5, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baddi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |