FDA Inspection 661114 — Quasar Bio-Tech, Inc.
The FDA completed an inspection of Quasar Bio-Tech, Inc. on May 11, 2010 in Yorba Linda, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yorba Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3837 | 21 CFR 820.25(b) | Training records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |