FDA Inspection 993559 — Bion Enterprises Ltd.
The FDA completed an inspection of Bion Enterprises Ltd. on Nov 18, 2016 in Des Plaines, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 18, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Des Plaines, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |