FDA 483 - Brisas del Caribe, Corp. - January 23, 2026

Brisas Del Caribe Corp, a warehouse and distribution facility in Canovanas, PR, was cited for two significant deficiencies during an FDA inspection. Inspectors observed that drug products were not stored under appropriate temperature conditions due to a lack of monitoring and control in the warehouse. Additionally, the firm's distribution system was found to be deficient, as it could not readily track product lots for recall purposes, and its recall SOP was inadequate.