FDA Inspection 823404 — Biocomposites, Ltd.
The FDA completed an inspection of Biocomposites, Ltd. on Mar 21, 2013 in Keele. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Keele (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |