FDA 483 - Renaissance Lakewood, LLC - August 22, 2019

An FDA inspection of Renaissance Lakewood, LLC, a contract pharmaceutical manufacturer in Lakewood, NJ, revealed two significant observations. The firm failed to thoroughly investigate out-of-specification drug product, specifically (b)(4) Oral Spray exhibiting a yellowish color, without establishing a definitive root cause. Additionally, the inspection found that the firm did not determine actual and theoretical yields for drug products, hindering proper process control and deviation investigations.