FDA 483 - Soaptronic LLC - February 14, 2020

Centronic LLC, a manufacturing facility in Lake Forest, CA, was inspected by the FDA from February 12-14, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate personnel, insufficient training, failure to reject out-of-specification raw materials, deficient laboratory controls, and compromised data integrity for electronic records. These issues indicate a serious lack of control over drug product manufacturing and quality assurance.