1099799
BAPS Swaminarayan Herbal Care, A Unit of Divine Energy — FEI 3004290879
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sabarkantha (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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |