FDA 483 - Zoetis LLC - May 03, 2021

This FDA Form 483 was issued to Zoetis LLC in Kalamazoo, MI, following an inspection of their drug manufacturing facility. The inspection revealed significant deficiencies primarily in aseptic processing, including environmental monitoring, cleaning, and contamination prevention. Additional concerns were raised regarding the quality control unit's authority and procedures, manufacturing process validation, and facility sanitation due to insect infestation.