858432

BTI Filtration — FEI 3003200197

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 12, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Oklahoma City, OK (United States)

Citations

IDCFRDescription
232821 CFR 820.22Quality audits - auditor independence
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation