FDA Inspection 868891 — Instratek, Incorporated
The FDA completed an inspection of Instratek, Incorporated on March 24, 2014 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2014
- Fiscal Year
- 2014
- 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 |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |