FDA 483 - Syenz Laboratory, LLC - March 05, 2020

Syenz Laboratory, LLC, an Own Label Distributor and Control Testing Laboratory in Norwood, NJ, received a Form 483 with eight observations related to significant deficiencies in its quality control, distribution, complaint handling, and laboratory control systems. The firm failed to adequately review batch records, maintain distribution documentation, establish complaint procedures, test components, ensure representative sampling, implement stability testing, conduct microbial testing, and retain reserve samples for its OTC drug products. These issues indicate a lack of robust quality oversight and control over its drug product manufacturing and distribution processes.