Form FDA 483 · Issued 2026-03-27
Allure Labs, LLC — FDA Form 483 Analysis
FEI: 3000204079 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Allure Labs, LLC (FEI 3000204079) on 2026-03-27 following an inspection of its manufacturer operations in California. The report documents 3 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Label Control, Undeclared Allergens & Structure/Function Claims.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written records kept in individual logs
Inspector Observation Language: "Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, observed during inspection of Allure Labs, LLC on 2026-03-27."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #2 · 21 CFR 211.125(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Strict control not exercised over labeling issued
Inspector Observation Language: "Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, observed during inspection of Allure Labs, LLC on 2026-03-27."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #3 · 21 CFR 211.46(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
REPEAT CITATION AT FACILITY
Equipment for Environmental Control
Inspector Observation Language: "Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, observed during inspection of Allure Labs, LLC on 2026-03-27."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.