1100282
JHS SVENDGAARD LABORATORIES LTD — FEI 3009223273
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Johron (India)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |