FDA Inspection 566149 — Bion Enterprises Ltd.
The FDA completed an inspection of Bion Enterprises Ltd. on Mar 2, 2009 in Des Plaines, IL. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Des Plaines, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 538 | 21 CFR 820.70(a) | Process control procedures |