FDA Inspection 1054669 — Keystone Industries

Keystone Industries — FEI 3010002722

The FDA completed an inspection of Keystone Industries on Jun 7, 2018 in Gibbstown, NJ. 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). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 7, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gibbstown, NJ (United States)

Citations

IDCFRDescription
185121 CFR 211.84(e)Rejecting When Specifications Not Met
358521 CFR 211.110(a)Control procedures to monitor and validate performance

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