FDA Inspection 739532 — Medicomp, Inc.
The FDA completed an inspection of Medicomp, Inc. on August 11, 2011 in Melbourne, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |