Cooler Heads Care, Inc. – FDA 483, Aug 6, 2026

Cooler Heads Care, Inc. in San Diego, CA, a medical device manufacturer, received a Form FDA 483 with three observations related to its quality system. The firm failed to maintain adequate records for supplier evaluations, did not investigate the root cause of nonconforming products, and neglected to incorporate post-production feedback into its risk management processes. Notably, some issues regarding supplier evaluations were repeat observations from a prior inspection.