FDA Inspection 842783 — Robbins Instruments, LLC
The FDA completed an inspection of Robbins Instruments, LLC on Jul 15, 2013 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 15, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |