FDA Inspections, Warning Letters and Import Refusals: Belgium
FDA has recorded 553 inspections of firms in Belgium, 11 of them (2.0%) classified OAI. It has issued 9 warning letters to firms there and refused 1,593 import shipments. 49 firms in Belgium are named on FDA import alerts.
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.
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By year
The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.
Belgium: FDA inspections per year
2017: 38 inspections 38 2017 2018: 39 inspections 39 2018 2019: 39 inspections 39 2019 2020: 8 inspections 8 2020 2021: 14 inspections 14 2021 2022: 29 inspections 29 2022 2023: 42 inspections 42 2023 2024: 34 inspections 34 2024 2025: 34 inspections 34 2025 2026: 9 inspections 9 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 9 0 0.0% 0 49 2025 34 1 2.9% 0 40 2024 34 0 0.0% 0 27 2023 42 0 0.0% 0 24 2022 29 1 3.4% 0 27 2021 14 0 0.0% 0 33 2020 8 0 0.0% 0 38 2019 39 0 0.0% 0 58 2018 39 0 0.0% 0 30 2017 38 0 0.0% 0 117
Latest OAI inspections
Date Facility Product type
Dec 18, 2025 DiAgam Societe Anonyme (S.A.) Devices Aug 12, 2022 LAMBO Laboratoria Food/Cosmetics Jul 29, 2015 Cardionics SA Devices Jan 15, 2015 Euromi S.A. Devices Sep 20, 2012 Medsys S.A. Devices Apr 7, 2011 Dr. Andre Vertruyen Biologics Jan 21, 2011 Baxalta Belgium Manufacturing SA Biologics Jun 10, 2010 Gynetics Medical Products NV Devices May 7, 2010 Laboratoria Qualiphar NV Drugs Oct 19, 2009 Baxalta Belgium Manufacturing SA Biologics Jan 22, 2009 Medibo N.V. Devices
Latest import refusals
Date Firm Product category
Sep 21, 2026 Belgo Prism Drugs and Biologics Sep 18, 2026 Alcon Laboratories Belgium Devices Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 15, 2026 Astra Sweets N.V. Human Foods Sep 9, 2026 Astra Sweets N.V. Human Foods Sep 9, 2026 Astra Sweets N.V. Human Foods Sep 9, 2026 Astra Sweets N.V. Human Foods Sep 9, 2026 Astra Sweets N.V. Human Foods Sep 2, 2026 Novartis Manufacturing NV Drugs and Biologics Aug 25, 2026 Organon Heist Drugs and Biologics Aug 6, 2026 LA MAISON DU PARFUM Drugs and Biologics Jul 30, 2026 Fertipro N.V. Devices Jul 21, 2026 Laboratoria Qualiphar NV Drugs and Biologics Jul 21, 2026 Laboratoria Qualiphar NV Drugs and Biologics Jul 21, 2026 Laboratoria Qualiphar NV Drugs and Biologics Jul 21, 2026 Laboratoria Qualiphar NV Drugs and Biologics Jul 13, 2026 H & O Equipments NV Devices Jul 13, 2026 RIZLA FACTORY LACROIX I FILS ETS Tobacco Products
Showing the latest 25 of 1,593.
Firms on FDA import alerts
Published Firm Import alert List
Oct 8, 2026 Astra Sweets N.V. 45-02 red Sep 30, 2025 GHO AHK SPRL 68-19 red Jul 3, 2025 Funghi Funghi NV 99-19 red Jan 9, 2023 LAMBO Laboratoria 54-14 red Mar 28, 2022 Kempico C.V. 99-45 red Dec 7, 2021 Biocartis Nv 89-08 red Jul 27, 2021 Coris Bioconcept 89-08 red Mar 2, 2021 ZenTech SA 89-08 red Jan 26, 2021 MULTI-G BVBA 89-08 red May 23, 2019 Dicogel Begro 99-08 red May 3, 2019 Casibeans 99-05 red May 23, 2017 IBC 45-02 red May 23, 2017 Ibc Belgium Bvba 45-02 red May 9, 2017 Beneo-Orafti, S.A. 99-08 red Dec 2, 2016 Carlier SPRL 45-02 red Nov 29, 2016 Medichin N.V. 68-19 red Aug 9, 2016 Vergo Kwekerijen BVBA 99-05 red Feb 12, 2016 W Cup Bvba 99-39 red Feb 12, 2016 W Cup Bvba 45-02 red Aug 5, 2015 Sunnyland 99-39 red Apr 6, 2015 De Prins Bvba 99-05 red Dec 10, 2014 Reprobiol Sprl 68-19 red Jun 3, 2014 Gowa 99-36 red Jun 3, 2014 Jonathan P.V.B.A. 99-37 red Jun 3, 2014 La Corbeille NV 99-38 red
Showing the latest 25 of 49.
Most-inspected facilities
Facility City Inspections OAI Latest
Novo Nordisk Production Belgium SA Brussels 12 0 Apr 7, 2023 Janssen Pharmaceutica, N.V. Beerse 10 0 Nov 21, 2025 Genzyme Flanders Geel 9 0 Sep 25, 2024 UCB Pharma S.A. Braine-L'Alleud 8 0 Jun 4, 2026 Janssen Pharmaceutica N.V. Geel 8 0 Mar 26, 2024 Cenexi Laboratoires Thissen SA Braine-L'Alleud 8 0 Jun 1, 2023 Organon Heist Heist-Op-Den-Berg 8 0 Jan 30, 2023 Baxalta Belgium Manufacturing SA Lessines 7 2 Nov 22, 2024 Sterigenics Belgium Petit-Rechain S.A. Verviers 7 0 Jun 29, 2023 SGS Lab Simon Wavre 6 0 Feb 16, 2026 Ajinomoto Omnichem NV Wetteren 6 0 Jun 13, 2025 Novartis Manufacturing NV Puurs-Sint-Amands 6 0 Mar 5, 2025 Zoetis Belgium S.A. Louvain-La-Neuve 6 0 May 21, 2024 Kaneka Eurogentec SA Seraing 6 0 Feb 26, 2024 PolyPeptide SA Braine-L'Alleud 6 0 Dec 18, 2023
See each facility's Form 483 observations with the FDA 483 search .