FDA Inspection 660426 — Teco Diagnostics, Inc.
The FDA completed an inspection of Teco Diagnostics, Inc. on April 26, 2010 in Anaheim, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2276 | 21 CFR 820.20(b)(1) | Responsibility, authority and independence |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3142 | 21 CFR 820.150(a) | Storage procedures to avoid release of unsuitable product |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4189 | 21 CFR 820.198(a) | General |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |