FDA Inspection 636989 — Epitope Diagnostics, Inc.
The FDA completed an inspection of Epitope Diagnostics, Inc. on December 16, 2009 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 16, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3241 | 21 CFR 820.72(b)(1) | Calibration standard traceability |
| 3839 | 21 CFR 820.70(a)(4) | Approval of process equipment |
| 537 | 21 CFR 820.70(a) | Production processes |
| 538 | 21 CFR 820.70(a) | Process control procedures |