Ol Pharma Tech LLC – FDA 483, Jul 10, 2026

OL Pharma Tech LLC, an OTC drug manufacturer in Madison Heights, MI, was cited for numerous significant quality control and manufacturing deficiencies during an FDA inspection. The firm failed to reject out-of-specification products, did not investigate repeated microbiological contamination, and lacked proper validation for equipment, processes, and analytical methods. These issues indicate a systemic failure in their quality management system, with many observations being repeats from previous inspections.