FDA Inspection 992245 — Water-Jel Technologies, LLC

Water-Jel Technologies, LLC — FEI 1219592

The FDA completed an inspection of Water-Jel Technologies, LLC on Nov 4, 2016 in Huntersville, NC. 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). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 4, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Huntersville, NC (United States)

Citations

IDCFRDescription
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
356521 CFR 211.58Buildings not maintained in good state of repair
439121 CFR 211.180(e)(2)Items to cover on annual reviews

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