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Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Alvotech Hf
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3013702557 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Alvotech Hf

Registered Address: Iceland (Iceland)

For Brand Buyers: Alvotech Hf carries a BB (59/100) rating due to documented FDA activity centered on Cleaning Validation, Sanitation Logs & Pest Control. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals · Resolved Name Aliases: Alvotech Hf
BB
59/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 90% of tracked 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
BB (59/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
71%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
67%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
7 Brands
~37 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3013702557's FDA Record

5 Questions to Ask Alvotech Hf 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 2026-05-08, FDA cited 21 CFR 211.42(c)(10)(v) (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-05-08, FDA cited 21 CFR 211.180(e) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-05-08, FDA cited 21 CFR 211.84(d)(2) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  4. Q4: 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?
  5. Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3013702557?

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 · 2026-05-08
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Alvotech Hf (FEI 3013702557) on 2026-05-08 following an inspection of its biological drug substance/product manufacturer operations in Iceland. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Finished Product Testing, Stability & Expiration Dating.

  • 21 CFR 211.42(c)(10)(v) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
  • 21 CFR 211.180(e) (Finished Product Testing, Stability & Expiration Dating): Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
  • 21 CFR 211.84(d)(2) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
  • 21 CFR 211.180(e)(2) (CAPA, Out-of-Specification (OOS) & Complaint Investigations): Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
  • 21 CFR 211.180(e)(1) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification. REPEAT OBSERVATION
OASIS Border Import Refusal (OASIS-2026-88107) · 2026-08-19
Port: Houston, TX · Charge: ADULTERATED DIETARY SUPPLEMENT — CGMP (FD&C Act 402(g)(1))
The dietary supplement appears to have been prepared, packed, or held under conditions that do not meet Dietary Supplement CGMP regulations (21 CFR Part 111).

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) 54/100
Materials & Incoming Identity 52/100
Production & Batch Records 47/100
Facilities, Sanitation & Pest 55/100
Laboratory & Stability Controls 52/100
Packaging & Allergen Labeling 64/100
Layer 6 · Clean-Record Sourcing Alternatives

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Lone Star Nutraceuticals & Gummy Works LLC (TX)
Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (59/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-05-08 -8.9 pts INSP-483-3013702557-20260508 ↗
Form 483 (5 observations, 1 repeat) 2026-05-08 -16.1 pts 483-3013702557-20260508 ↗
Import Refusal (ADULTERATED DIETARY SUPPLEMENT — CGMP) 2026-08-19 -7.6 pts OASIS-2026-88107 ↗