FDA Inspection 1093674 — JW North America, Inc.
The FDA completed an inspection of JW North America, Inc. on Jun 20, 2019 in Rockland, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 20, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rockland, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |