FDA Inspection 633707 — BioSerenity USA, Inc.
The FDA completed an inspection of BioSerenity USA, Inc. on Jan 5, 2010 in Glen Burnie, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glen Burnie, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |