FDA Inspection 935117 — Affymetrix, Inc.
The FDA completed an inspection of Affymetrix, Inc. on Jul 29, 2015 in Santa Clara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 29, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |