Dietary Supplement CoAs: When Is Supplier Reliance Allowed?
A supplier certificate of analysis does not automatically replace dietary-ingredient identity testing. Part 111 treats identity verification and permitted CoA…
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Category: Dietary Supplements
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Dietary Supplement Reserve Samples: Quantity, Storage and Retention
Part 111 requires reserve samples from each distributed lot of packaged and labeled dietary supplements. The quantity and retention rules…
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Dietary Supplement Reprocessing: What Quality Control Must Document
Reprocessing is not a routine way to release a nonconforming supplement. Part 111 requires material review, a documented disposition decision,…