FDA Inspection 1094810 — Sarasota Medical Products, Inc.
The FDA completed an inspection of Sarasota Medical Products, Inc. on June 12, 2019 in Sarasota, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |