FDA 483 - Pharmavite LLC dba Nature Made - August 27, 2021

An FDA inspection of Pharmavite LLC dba Nature Made in San Fernando, CA, a dietary supplement manufacturer, revealed significant deficiencies across its operations. Observations included inadequate laboratory control processes for specifications, failure to reject non-conforming products, insufficient in-process monitoring, and unvalidated microbial test methods. Additionally, issues with documentation, facility sanitation, and equipment cleaning procedures were noted, indicating systemic quality control failures.