FDA Inspection 1066267 — Footprint Medical, Inc.
The FDA completed an inspection of Footprint Medical, Inc. on September 21, 2018 in San Antonio, TX. 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
- September 21, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 537 | 21 CFR 820.70(a) | Production processes |
| 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 |