FDA Inspection 918709 — Wexler Surgical, Inc.
The FDA completed an inspection of Wexler Surgical, Inc. on March 20, 2015 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 20, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |