1257012
Healwell Homeo Private Limited — FEI 3028192440
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 20, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |