Chemco Corporation – FDA Warning Letter, Aug 22, 2025

Chemco Corporation, located in Miami Lakes, Florida, received an FDA warning letter following an inspection conducted from August 11 to 22, 2025. The investigation revealed significant failures to meet Current Good Manufacturing Practice (CGMP) standards, as defined by the Federal Food, Drug, and Cosmetic Act. These violations indicate that the company’s over-the-counter (OTC) drug products are considered substandard and potentially unsafe for consumers. Key violations included inadequate cleaning procedures for shared equipment, which resulted in visible residue and high risks of cross-contamination between different products. The company also failed to perform essential identity tests on incoming ingredients, including high-risk materials that must be screened for dangerous contaminants like diethylene glycol. Additionally, the quality control department provided insufficient oversight, failing to validate manufacturing processes or properly investigate product failures. The FDA further identified several products, such as "PRO Nail FUNGUS KILLER," as unapproved new drugs because they claim to treat conditions like nail fungus without federal authorization. Other products were found to be misbranded due to misleading labels—such as suggesting FDA endorsement through facility registration claims—and for failing to include mandatory "Drug Facts" safety information. To resolve these issues, Chemco must perform a thorough retrospective review of its cleaning and testing practices. The company is required to submit a comprehensive corrective action plan, conduct risk assessments for all distributed products, and establish robust quality oversight. The FDA also strongly advised the firm to hire an independent consultant to assist in achieving compliance. Failure to correct these deficiencies promptly could lead to legal consequences, including product seizures or manufacturing injunctions.