FDA 483 - Small Beginnings, Inc. - June 23, 2021

An FDA inspection of Small Beginnings, Inc., a medical device manufacturer in Hesperia, CA, revealed two significant quality system deficiencies. The firm lacked adequate procedures for controlling nonconforming product and for conducting quality audits, and had not performed any audits as required. These observations indicate a fundamental breakdown in establishing and maintaining a compliant quality system.