FDA Inspection 774844 — Antibodies Inc
The FDA completed an inspection of Antibodies Inc on March 21, 2012 in Davis, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Davis, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |