Sun Sen Co., Inc. Warning Letter Details

Summary

Sun Sen Co., Inc., a sprout growing and food repacking facility in Sacramento, California, received a warning for producing adulterated alfalfa and clover sprout products prepared under insanitary conditions that may have been contaminated with filth or rendered injurious to health. FDA investigators identified serious violations of the Produce Safety Regulation (21 CFR Part 112) and the Current Good Manufacturing Practice & Preventive Controls rule (21 CFR Part 117), including failure to establish and implement a written environmental monitoring plan. The company had not responded to the FDA Form 483 Inspectional Observations issued at the close of the inspection on April 11, 2022.