FDA 483 - Adept Life Science, LLC - August 27, 2025
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Adept Life Sciences, LLC received a Form 483 citing multiple repeat observations related to quality control failures in dietary supplement manufacturing. Key issues include releasing products that did not meet specifications, inadequate testing and approval of components, and a lack of established specifications for both raw materials and finished products. The firm also failed to establish scheduled processes for acidified foods and released products without proper QA approval or when out-of-specification results were known.
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- Denver District Office
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ID · 5bcb9b4f-effc-4a90-add6-1cbe621636a6