RUO IVD Products: Why the Label Alone Does Not Set Intended Use
A research-use-only statement must be consistent with the manufacturer’s intended use. FDA’s RUO/IUO guidance looks beyond the presence of a…
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IVD Reagent Lot Traceability: From Kit Label to Production History
IVD labeling requirements include a lot or control number traceable to production history. A readiness review should test the connection…
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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,…
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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 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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Cosmetic Safety Substantiation: Does FDA Require a Specific Test?
FDA does not prescribe one universal test list for cosmetic safety substantiation. The responsible person still needs adequate supporting safety…
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Cosmetic Adverse-Event Records: Six Years or Three Years?
Cosmetic adverse-event records generally have a six-year retention period. A qualifying small responsible person may have a three-year period under…
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Cosmetic Responsible Person vs Contract Manufacturer Under MoCRA
Under MoCRA, the responsible person is identified through the cosmetic label. Using a contract manufacturer does not, by itself, make…
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Can an FDA Mock Inspection Be Done Virtually? What a Remote Simulation Should Test
Discover how a virtual FDA mock inspection stress-tests your quality systems without disrupting active production schedules. As federal regulators expand…
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Nutraceutical FDA Inspections: GMP, Claims and Labeling Risks to Check Now
Prepare your wellness brand for an FDA nutraceutical inspection under 21 CFR Part 111. While the commercial market uses the…
