FDA Inspection 611543 — Bioresource Technology Inc
The FDA completed an inspection of Bioresource Technology Inc on September 3, 2009 in Weston, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |