FDA Inspection 721927 — Work Inc.
The FDA completed an inspection of Work Inc. on April 14, 2011 in Dorchester, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dorchester, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |