Ethylene and Diethylene Testing - Warning Letter

Higley Industries' drug facility received a Warning Letter from the US Food and Drug Administration (FDA) for significant breaches of Good Manufacturing Practices (CGMP). The FDA's inspection identified failures in testing component samples for identity and compliance with purity, strength, and quality specifications. Notably, ethanol lacked methanol testing, while glycerin lacked identity testing, posing risks of contamination with diethylene glycol (DEG) or ethylene glycol (EG). The water system's suitability for drug production was also questioned.

To address these issues, the company must implement batch testing for compliance, validate supplier certifications, conduct specific identity testing for high-risk components like glycerin, and establish quality control specifications. Supplier qualification and material control systems must be reviewed, and protocols for water system monitoring and microbial testing must be developed to meet USP monograph specifications. Risk assessments for DEG or EG contamination are also required.