FDA Inspection 1205196 — BTI Filtration

BTI Filtration — FEI 3003200197

The FDA completed an inspection of BTI Filtration on May 11, 2023 in Oklahoma City, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Oklahoma City, OK (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures