FDA Inspection 1195720 — KDC/ONE Development Corporation, Inc.

KDC/ONE Development Corporation, Inc. — FEI 3003690512

The FDA completed an inspection of KDC/ONE Development Corporation, Inc. on January 27, 2023 in Knowlton. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 27, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Knowlton (Canada)

Citations

IDCFRDescription
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test