Form FDA 483 · Issued 2026-03-27
Q-Med AB — FDA Form 483 Analysis
FEI: 3003347293 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Substance and Drug product Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Q-Med AB (FEI 3003347293) on 2026-03-27 following an inspection of its drug substance and drug product manufacturer operations in Sweden. The report documents 2 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 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 Q-Med AB 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 #2 · 21 CFR 211.46(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
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 Q-Med AB 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.