FDA Inspection 665791 — BioCheck, Inc.
The FDA completed an inspection of BioCheck, Inc. on June 9, 2010 in South San Francisco, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 9, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- South San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |