FDA Inspection 1014186 — Rex Medical LP
The FDA completed an inspection of Rex Medical LP on April 19, 2017 in Conshohocken, PA. 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
- April 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Conshohocken, PA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |