FDA Inspection 994514 — Nurse Assist, LLC
The FDA completed an inspection of Nurse Assist, LLC on November 23, 2016 in Haltom City, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 23, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Haltom City, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 3696 | 21 CFR 820.100(b) | Documentation |