FDA Inspection 684594 — SCI Medic, Inc.
The FDA completed an inspection of SCI Medic, Inc. on October 13, 2010 in Frederick, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 13, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |