FDA Inspection 810166 — Human Biosciences, Inc.
The FDA completed an inspection of Human Biosciences, Inc. on January 4, 2013 in Gaithersburg, MD. 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
- January 4, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gaithersburg, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |