FDA 483 - Aurobindo Pharma USA Inc - May 15, 2025

Shaklee Corporation, a dietary supplement manufacturer in Pleasanton, CA, was inspected by the FDA from July 8-19, 2019. This inspection served as a follow-up to a previous Warning Letter and identified significant deviations from Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, specifically 21 CFR Part 111.

Key violations included the firm's failure to establish and adhere to laboratory control processes that require review and approval by quality control personnel. Specifically, there was no quality control oversight for component, packaging, and label testing results, and the company failed to perform identity testing for several dietary ingredients—a repeat observation. Another critical repeat observation was the absence of established in-process specifications for crucial manufacturing stages of dietary supplement tablets, such as tablet weight, thickness, and friability. Furthermore, the firm's Quality Control unit released multiple product lots where manufacturing operations, like tablet weights, consistently did not conform to the established master manufacturing record.

During the inspection close-out, President and CEO Emanuel T. Fakoukakis and other management acknowledged the observations and committed to implementing corrective actions. The FDA expects a comprehensive response outlining the company's plan to address these systemic compliance issues.