FDA Inspection 989444 — Neogen Corporation
The FDA completed an inspection of Neogen Corporation on Oct 7, 2016 in Lansing, MI. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 7, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |