FDA 483 - ATTWILL Medical Solutions LP - November 04, 2016

Anteco Pharma LLC, a lyophilization contractor in Lodi, WI, was cited for multiple significant deficiencies related to manufacturing controls and sanitation. The inspection revealed failures in cleaning procedures, inadequate equipment qualification and process validation, and insufficient environmental monitoring, all contributing to potential product contamination. These issues indicate a lack of robust quality systems to ensure product safety and integrity.