FDA Inspection 584653 — Medtrol, Inc.
The FDA completed an inspection of Medtrol, Inc. on Jun 1, 2009 in Niles, IL. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2270 | 21 CFR 820.20(a) | Implement quality policy |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3691 | 21 CFR 820.100(a)(4) | Verification vs validation |
| 4189 | 21 CFR 820.198(a) | General |