FDA Inspection 1167029 — Med Pen Concepts, LLC
The FDA completed an inspection of Med Pen Concepts, LLC on April 13, 2022 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |