FDA 483 - Pharmacaribe llc - August 20, 2025

Pharmacaribe, LLC, a specification developer in Punta Gorda, FL, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including failures in complaint handling, organizational structure, quality audits, CAPA documentation, management reviews, and Device Master Record maintenance. Several observations were repeats from a previous inspection, indicating persistent issues.