FDA 483 - Pharmavite LLC dba Nature Made - August 27, 2021
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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.
ID · 251a762a-e948-49d2-9c56-bf9b22d10bc1