FDA 483 - Galephar Pharmaceutical Research Inc. - October 18, 2024

Galephar Pharmaceutical Research Inc. in Juncos, PR, was inspected by the FDA from October 15-18, 2024. The inspection revealed a significant issue regarding the firm's failure to investigate unexplained discrepancies in batch production and control records. Specifically, unvalidated equipment was used during the manufacturing of Tramadol Extended Release Capsules without proper investigation or scientific justification.