FDA Inspection 888763 — VertiFlex, Inc.
The FDA completed an inspection of VertiFlex, Inc. on July 25, 2014 in Carlsbad, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Carlsbad, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |