FDA Inspection 749713 — Better Water LLC

Better Water LLC — FEI 1000112932

The FDA completed an inspection of Better Water LLC on October 6, 2011 in Smyrna, TN. 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
October 6, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Smyrna, TN (United States)

Citations

IDCFRDescription
233921 CFR 820.22Quality Audit/Reaudit - documentation
320421 CFR 820.40(b)Change records, content