FDA 483 - Purolea Cosmetics Lab - October 30, 2025

Purolea Cosmetics Lab, a homeopathic drug manufacturer in Livonia, MI, was cited for significant deficiencies in its manufacturing processes and quality control. The inspection revealed a lack of proper batch records, inadequate product testing, insufficient component identity testing, and an absence of written procedures for quality control, stability, and process validation. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices (cGMPs) for drug products.