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

An FDA Form 483 was issued to a repacker and warehouse facility located in Boca Raton, Florida, following an inspection conducted from July 7-11, 2025. The observations, addressed to the Director of Quality, highlight deficiencies in quality control and process management under the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure to establish adequate written procedures for production and process controls. Specifically, the firm did not perform a temperature mapping study for storage areas holding temperature-sensitive drug products, leading to unverified temperature fluctuations potentially compromising product stability. Additionally, the computerized system used to monitor critical environmental parameters lacked recent system verification.

The inspection also noted a lack of written procedures for in-process controls during packaging operations, which impacts batch uniformity for distributed products. Furthermore, batch production and control records were incomplete, failing to document critical packaging steps taken to protect products from specific environmental factors. These omissions mean that essential process details, though performed by technicians, are not formally recorded. The company is expected to implement comprehensive corrective actions to address these significant deviations and ensure compliance with regulatory standards for drug product manufacturing and storage.