FDA 483 - Arzol Chemical Company - June 14, 2024

Arzol Chemical Company, a drug manufacturer in Keene, NH, received a Form 483 with four observations. The inspection revealed significant issues including inadequate process validation for Silver Nitrate Applicators, insufficient testing of incoming Active Pharmaceutical Ingredients, and a deficient vendor qualification program for contract laboratories. Additionally, the firm lacked adequate systems for Drug Supply Chain Security Act compliance.