FDA Inspection 896217 — Action Products Incorporated
The FDA completed an inspection of Action Products Incorporated on Sep 19, 2014 in Hagerstown, MD. 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
- Sep 19, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hagerstown, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |