FDA Inspection 730360 — BioCheck, Inc.
The FDA completed an inspection of BioCheck, Inc. on June 17, 2011 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- South San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |