483
Galephar Pharmaceutical Research Inc.Galephar Pharmaceutical Research Inc. – FDA 483, Oct 18, 2024
Record Details
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.
View Company Profile
ID · 5f826b5e-84a6-4b50-9060-fc43caa37ad1
Other documents for Galephar Pharmaceutical Research Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.