FDA Inspection 538654 — IVD Research, Inc.
The FDA completed an inspection of IVD Research, Inc. on October 9, 2008 in Carlsbad, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 9, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |