FDA Inspection 609807 — Apieron, Inc.
The FDA completed an inspection of Apieron, Inc. on August 28, 2009 in Menlo Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Menlo Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |