FDA Inspection 1257384 — Quasar Bio-Tech, Inc.
The FDA completed an inspection of Quasar Bio-Tech, Inc. on December 20, 2024 in Yorba Linda, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 20, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Yorba Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |