976447
Lymol Medical Corporation — FEI 1221129
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |