FDA Inspection 874256 — Luminex Corporation
The FDA completed an inspection of Luminex Corporation on April 4, 2014 in Northbrook, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northbrook, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |