FDA 483 - Galephar Pharmaceutical Research Inc. - January 20, 2023

Galephar Pharmaceutical Research Inc. in Humacao, PR, was inspected by the FDA, resulting in two observations. The inspection revealed failures in thoroughly reviewing unexplained discrepancies related to drug product batch yields and inadequate equipment maintenance. These issues included a lack of a preventive maintenance plan and unreported damage to product contact parts, indicating potential concerns with quality control and manufacturing practices.