FDA 483 - Southern Sales & Services Inc. - March 29, 2019

Southern Sales & Services Inc., an own-label distributor in Fort Lauderdale, FL, was cited for significant deficiencies in its quality control system. The inspection revealed the absence of a quality control unit, inadequate training, unapproved procedures, and failures in managing contract manufacturers, change controls, and annual product reviews. Additionally, the firm failed to properly handle consumer complaints, quarantine drug products, and establish adequate acceptance criteria for product release.