FDA 483 - Veltek Associates, Inc. - November 14, 2018

Veltek Associates, Inc., a drug product packager in Malvern, PA, was cited for significant deficiencies during an FDA inspection. Observations included a lack of qualification for packaging equipment and inadequate preventative maintenance. Additionally, the firm failed to implement appropriate controls over computerized laboratory systems, allowing unauthorized data deletion, and lacked annual product review procedures for Decon-Hand.