FDA Inspection 762219 — Neogen Corporation

Neogen Corporation — FEI 1120041

The FDA completed an inspection of Neogen Corporation on January 9, 2012 in Lansing, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 9, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Lansing, MI (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
383721 CFR 820.25(b)Training records
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures