Vi-Jon, LLC

Warning LetterClosed

Mr. Richard Koulouris Chairman and CEO Vi-Jon, LLC 8800 Page Avenue St. Louis , MO 63114 United StatesFEI 1941150Issued Mar 31, 2022Division of Pharmaceutical Quality Operations III

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Letter Details

Firm: Vi-Jon, LLC
Location: Mr. Richard Koulouris Chairman and CEO Vi-Jon, LLC 8800 Page Avenue St. Louis , MO 63114 United States
FEI Number: 1941150
Country: United States
Issue Date: March 31, 2022
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Closed
Closeout Letter: March 15, 2024

Summary

Vi-Jon, LLC's manufacturing facility for over-the-counter drug products, including benzalkonium chloride-based hand sanitizer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA identified that the company failed to establish adequate laboratory controls with scientifically sound specifications and test procedures, specifically citing an insufficient water sampling plan that did not represent the overall system variability across all points of use in production operations. The company's response to FDA Form 483 observations was deemed inadequate due to lack of sufficient detail and evidence of corrective actions needed to achieve CGMP compliance, resulting in the drug products being classified as adulterated.