CDL Services, Inc. DBA Technichem – FDA Warning Letter, Apr 28, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to CDL Services, Inc. DBA Technichem following an inspection from April 7 to 28, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, classifying the company"s drug products, including hand sanitizers and hand soap, as adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations include the firm"s failure to adequately test finished drug products for the identity and strength of active ingredients like ethanol and chloroxylenol before release. The company admitted to using "simulated results" and not performing actual finished product testing for over a year, leading to the distribution of products without ensuring they met final specifications. Additionally, CDL Services, Inc. failed to test incoming components for identity and conformity to specifications. This included a lack of identity testing for critical components such as glycerin, ethanol, and chloroxylenol, and not validating supplier test results. Specifically, the FDA noted the absence of testing for methanol contamination in ethanol and diethylene glycol/ethylene glycol (DEG/EG) contamination in high-risk components like glycerin and propylene glycol. The suitability of water used in manufacturing was also not demonstrated. The FDA requires CDL Services, Inc. to provide a comprehensive list of chemical and microbial specifications with test methods for all drug products, an action plan and timeline for full testing of retain samples, and a summary of results with proposed corrective actions for any substandard products. Furthermore, the company must submit a detailed plan for assessing components against compendial requirements, including test methods and timelines for implementing corrective measures.