FDA Inspection
Immaculate Labz, LLCImmaculate Labz, LLC – FDA Inspection, Sep 6, 2024
Record Details
This FDA Inspection record concerns Immaculate Labz, LLC, with an inspection on September 6, 2024, issued by the Dallas District Office, covering foods & cosmetics.
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ID · d5904134-2d1f-4fb2-8b8f-be8ff795f100
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249323
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 111.103Written procedures - establish; quality control operations
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.353Written procedures - establish; manufacturing operations
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
- 21 CFR 111.503Written procedures - establish; returned dietary supplements
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.80(a)Components packaging, labels used
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