FDA 483 - Figuerola Group, Inc. dba Figuerola Laboratories - February 28, 2023

Figueroa Group, Inc. dba Figueroa Laboratories in Buellton, CA, was inspected by the FDA, resulting in seven observations primarily concerning inadequate quality control for dietary supplements. The firm failed to establish proper specifications for finished products and components, did not qualify suppliers, and exhibited poor sanitation practices. Additionally, deficiencies were noted in master manufacturing records and batch production records, indicating significant gaps in their manufacturing process controls.