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FDA Inspections, Warning Letters and Import Refusals: Poland

FDA has recorded 666 inspections of firms in Poland, 15 of them (2.3%) classified OAI. It has issued 11 warning letters to firms there and refused 5,579 import shipments. 111 firms in Poland 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.

All countries · Check one supplier with the free FDA compliance check.

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.

Poland: FDA inspections per year 2017: 77 inspections7720172018: 57 inspections5720182019: 47 inspections4720192020: 11 inspections1120202021: 4 inspections420212022: 18 inspections1820222023: 26 inspections2620232024: 60 inspections6020242025: 55 inspections5520252026: 21 inspections212026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20262100.0%01,963
20255523.6%0863
20246011.7%162
20232613.8%078
20221800.0%179
2021400.0%145
20201100.0%095
20194700.0%041
20185711.8%070
20177711.3%188

Latest OAI inspections

DateFacilityProduct type
Oct 29, 2025ClavmedDevices
Jul 2, 2025Okregowa Spoldzielnia Mleczarska W LowiczuFood/Cosmetics
May 23, 2024CLUNAS SP. Z O.O. ULDevices
May 19, 2023Konrad Rejdak, M.D.Biologics
Sep 4, 2018Rauch Polska Sp. Zo.O.Food/Cosmetics
Mar 7, 2017Wilbo S.A.Food/Cosmetics
Nov 7, 2014Chlodnia Grudziadz Sp. Z O.O.Food/Cosmetics
Feb 14, 2014Steriscience SP. Z O.O.Drugs
Jan 31, 2014Provitus Dabrowscy ,Malesa S.J.Food/Cosmetics
Jan 21, 2014AGRO-SERWISFood/Cosmetics
Feb 7, 2012Przetworstwo Ryb ProrybFood/Cosmetics
Jan 27, 2012Smak Sp. Z O.O.Food/Cosmetics
Dec 13, 2011Seko Sp. Z O.O.Food/Cosmetics
Sep 15, 2011Nobilus Ent Oddzial KutnoDrugs
Oct 22, 2010Przedsiebiorstwo Farmaceutyczne Jelfa SADrugs

Latest warning letters

DateFirmProduct typeFDA center
May 29, 2024Konrad Rejdak, M.D.BiologicsCBER
Mar 16, 2022Dr Retter Ec Retter WladyslawDrugsCDER
Nov 4, 2021BIONATEO SP ZOODrugsCDER
Aug 8, 2017Wilbo S.A.Food/CosmeticsCFSAN
May 12, 2015Chlodnia Grudziadz Sp. Z O.O.Food/CosmeticsCFSAN
Jul 17, 2014AGRO-SERWISFood/CosmeticsCFSAN
Jul 17, 2014Provitus Dabrowscy ,Malesa S.J.Food/CosmeticsCFSAN
Oct 16, 2012Superfish S.A.Food/CosmeticsCFSAN
May 15, 2012Smak Sp. Z O.O.Food/CosmeticsCFSAN
Mar 7, 2012Nobilus Ent Oddzial KutnoDrugsCDER
Jul 14, 2011Przedsiebiorstwo Farmaceutyczne Jelfa SADrugsCDER

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 22, 2026FEDRS SP ZOOTobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026FEDRS SP ZOOTobacco Products
Oct 22, 2026FEDRS SP ZOOTobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 22, 2026Luna CorporateTobacco Products
Oct 21, 2026NEOPTOLEM LLCTobacco Products
Oct 21, 2026FEDRS SP ZOOTobacco Products
Oct 21, 2026FEDRS SP ZOOTobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026FEDRS SP ZOOTobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products
Oct 21, 2026Snus Fusion Sp. Z O.O.Tobacco Products

Showing the latest 25 of 5,579.

Firms on FDA import alerts

PublishedFirmImport alertList
Sep 25, 2026MASFROST Sp. Z O.O.99-08red
Aug 31, 2026PETMEX71-04red
Jul 27, 2026FEDRS SP ZOO98-06red
Jul 27, 2026FEDRS SP. Z O.O98-06red
Jul 13, 2026NICOMPOLAND SP. Z O.O., UL.98-06red
Jul 6, 2026PROMOTORZY TRADING SP .ZO.O.SP98-08red
May 8, 2026SPECTRUM LEAF CANNADIPS98-06red
Apr 21, 2026ICEBERG TOBACCO SP Z.O.O98-06red
Apr 10, 2026Fffood Sp. Z.O.O.99-32red
Apr 10, 2026Gomar Pinczow Sp. Z O.O. SKA99-32red
Apr 7, 2026NICOTOBACCO FACTORY98-06red
Apr 6, 2026TOBACCO INTERNATIONAL98-06red
Feb 6, 2026Okregowa Spoldzielnia Mleczarska W Lowiczu99-38red
Jan 16, 2026DAWTONA Sp.Zo.O99-38red
Dec 1, 2025ICEBERG NICOTINE98-06red
Oct 27, 2025BABORD VAP SP Z O O16-39red
Oct 22, 2025NICOTOBACCO98-06red
Jun 26, 2025BABORD VAP SP Z O O16-125red
Jun 2, 2025Minex Centrala Eksportwo - Importowa99-45red
May 19, 2025Universal Pet Treats71-04red
May 13, 2025Tymbark-MWS Sp. Z O.O. S.K.A99-45red
Mar 7, 202577 POUCHES98-06red
Mar 7, 2025Luna Corporate98-06red
Feb 7, 2025DERMATRADE SP Z.O.O89-08red
Dec 27, 2022Przedsiebiorstwo Handlu Zagranicznego Kasol J.A. Kazberuk99-08red

Showing the latest 25 of 111.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Przedsiebiorstwo Farmaceutyczne Jelfa SAJelenia Gora71Mar 21, 2025
DSM Nutritional Products Sp. Z.O.O.Buk70Mar 14, 2023
Zaklady Farmaceutyczne Polpharma S.A.Starogard Gdanski50Oct 17, 2025
Nobilus Ent Oddzial KutnoKutno51May 9, 2024
Artur Racewicz, MD, PhDBialystok40Aug 22, 2024
Steriscience SP. Z O.O.Warsaw41Feb 9, 2024
Edward Franek MDWarsaw40Sep 29, 2023
Przedsiebiorstwo Produkcyjno Wdrozeniowe Ifotam Sp ZOO ZaklaLodz40Mar 28, 2022
Krzysztof W. Selmaj, M.D., Ph.D.Lodz40Sep 23, 2016
Zbigniew I. NoweckiWarsaw30Feb 19, 2026
Joanna Zdziarska, MD, PhDCracow30Jan 16, 2026
Bartosz Korczowski, MD., PhDRzeszow30Oct 31, 2025
Grazyna Pulka, M.D.Cracow30Jun 12, 2025
Janusz Jaworski, M.D., Ph.DWarsaw30Aug 29, 2024
Wojciech Jurczak, MD., PhD.Cracow30May 9, 2024

See each facility's Form 483 observations with the FDA 483 search.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.