KVK-Tech Warning Letters: A Timeline of Regulatory Assessments

FDA issued KVK-Tech, Inc (Newtown, PA) a Warning Letter on October 8, 2020, based on the outcome of an inspection ending March 13, 2020 (Link to the corresponding FDA 483). Additionally, the firm had also received a Warning Letter on February 11, 2020, based on the outcome of an inspection ending April 16, 2019 (Link to the corresponding FDA 483)

KVK-Tech is identified as a drug packaging operation. In the October Warning Letter, FDA noted that similar GMP violations have been identified at other facilities owned by the firm, but did not reference the Warning Letter from February. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate”

This document illustrates the chronology of the documentation arising as an outcome to the inspections across sites for KVK-Tech in the past few years: