FDA Inspection 556414 — ITC Nexus Dx
The FDA completed an inspection of ITC Nexus Dx on Jan 7, 2009 in Piscataway, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 35 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Piscataway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3241 | 21 CFR 820.72(b)(1) | Calibration standard traceability |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 3670 | 21 CFR 820.20(c) | Management review participants |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3702 | 21 CFR 820.250(a) | Appropriateness |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 4189 | 21 CFR 820.198(a) | General |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |