FDA 483 - Reliable Healthcare Logistics LLC - July 11, 2025

Reliable Healthcare Logistics LLC, a repacker and warehouse in Boca Raton, FL, received an FDA Form 483 with three observations. The firm failed to establish adequate written procedures for production and process controls, including temperature mapping studies and verification of computerized environmental monitoring systems. Additionally, the company lacked written procedures for in-process controls during packaging and maintained incomplete batch production records regarding product protection.