Ken Prima Cosmeceuticals, Sdn. Bhd. – FDA 483, Nov 17, 2023

Ken Prima Cosmeceuticals, Sdn. Bhd. in Perai, Malaysia, was cited for significant data integrity issues and widespread failures in quality control and manufacturing processes during an FDA inspection. Observations included fabricated laboratory and stability data, lack of thorough investigations into out-of-specification results, and inadequate process validation and equipment cleaning procedures. These deficiencies indicate a severe lack of adherence to cGMP requirements, potentially impacting the quality and safety of their OTC drug products for the US market.