FDA 483 - Arzol Chemical Company - July 14, 2024

The Food and Drug Administration (FDA) conducted an inspection of Arzol Chemical Company, a drug manufacturer, from June 10-14, 2024. The inspection resulted in a Form FDA 483, highlighting several significant observations related to regulatory compliance. Key issues included the company's failure to establish adequate written procedures for production and process controls, specifically regarding the insufficient validation of a major manufacturing process change for Silver Nitrate Applicators. This lapse affects the identity, strength, purity, and quality assurance of distributed drug products.

Furthermore, the FDA noted that incoming Active Pharmaceutical Ingredients, such as Silver Nitrate, were not consistently tested for purity, strength, and identity, with the company relying on supplier certificates—a repeat observation from a 2016 inspection. Deficiencies were also identified in the vendor qualification program for contract laboratories used for analytical testing, which lacked documentation of FDA registration, method suitability, and on-site audits. Finally, Arzol Chemical Company's systems and processes for complying with the Drug Supply Chain Security Act (DSCSA) were deemed inadequate, particularly concerning the verification of product identifiers and the identification and response to suspect or illegitimate products. Arzol Chemical Company is required to implement comprehensive corrective actions to address these observations and ensure compliance with regulatory standards.