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Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Q-Med AB
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3003347293 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Q-Med AB

Registered Address: Sweden (Sweden)

For Brand Buyers: Q-Med AB carries a BBB (78/100) rating due to documented FDA activity centered on Label Control, Undeclared Allergens & Structure/Function Claims. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Q-Med AB
BBB
78/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 68th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BBB (78/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
81%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
4 Brands
~16 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3003347293's FDA Record

5 Questions to Ask Q-Med AB Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: On 2026-03-27, FDA cited 21 CFR 211.125(a) (Label Control, Undeclared Allergens & Structure/Function Claims). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-03-27, FDA cited 21 CFR 211.46(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3003347293?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

Form FDA 483 Issued · 2026-03-27
Open Full 483 Analysis & Dossier →

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.

  • 21 CFR 211.125(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
  • 21 CFR 211.46(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 81/100
Materials & Incoming Identity 79/100
Production & Batch Records 80/100
Facilities, Sanitation & Pest 74/100
Laboratory & Stability Controls 79/100
Packaging & Allergen Labeling 75/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (78/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-03-27 -8.7 pts INSP-483-3003347293-20260327 ↗
Form 483 (2 observations, 0 repeat) 2026-03-27 -5.2 pts 483-3003347293-20260327 ↗