FDA 483 - Soaptronic LLC - April 28, 2025

Soaptronic LLC, an OTC drug manufacturer in Lake Forest, CA, was cited for numerous deficiencies during an FDA inspection from April 22-28, 2025. Key issues include failures in process validation, yield determination, OOS investigations, annual product reviews, employee training, supplier qualification, label control, laboratory recordkeeping, equipment calibration, and computer system access controls. Several observations, including employee training and computer system controls, were noted as repeat deficiencies, indicating systemic quality control problems.