fda-inspection-records

FDA inspections of firms in Sweden

201 firms in Sweden inspected by the FDA (fiscal years 2009–2026). Most serious classification on file: 76 NAI, 107 VAI, 18 OAI.

PlaceFirmProduct typesInspectionsLatest inspection483 observations posted
AlvsjoO. Kavli
FEI 2000009425
Food/Cosmetics1Oct 7, 2014 · VAI—
AngelholmHemoCue AB
FEI 3003044483
Biologics; Devices3May 31, 2018 · VAI6
AngelholmLinxens Sweden AB
FEI 3012606445
Devices1Nov 7, 2024 · VAI2
ArstaRecipharm Stockholm AB
FEI 3002806286
Drugs5Jun 5, 2019 · VAI2
AskersundAbigo Medical AB
FEI 3009750086
Devices1Feb 2, 2018 · NAI—
AskimOticon Medical Ab
FEI 3007367732
Devices1Feb 20, 2014 · VAI3
AsljungaContinental Bakeries North Europe AB
FEI 3008837354
Food/Cosmetics1Aug 30, 2013 · NAI—
AtvidabergPartnertech Ab
FEI 3002912904
Devices1Mar 26, 2010 · VAI3
AtvidabergScanfil Atvidaberg AB
FEI 3008727520
Devices2Sep 27, 2018 · NAI—
BilldalIngenjorsfirman Bjorn Bergdahl AB (IBBAB)
FEI 3004605354
Devices2Feb 12, 2015 · NAI—
BilldalUnfors RaySafe AB
FEI 3004488375
Devices1Sep 3, 2014 · VAI1
BjurholmAB Nyakers Pepparkakor
FEI 3010358180
Food/Cosmetics2May 24, 2019 · VAI3
BjuvFindus Sverige Ab
FEI 3003732874
Food/Cosmetics1Aug 19, 2013 · NAI—
BredarydNATIONAL BREDARYD PERFORMANCE POLYMERS AB
FEI 3015989071
Devices1Jun 27, 2024 · VAI—
BuaSwedish Oat Fiber AB
FEI 3009541989
Food/Cosmetics1Sep 3, 2013 · NAI—
BurtraskNorrmejerier, Burtrask mejeri
FEI 3009993830
Food/Cosmetics1Oct 23, 2014 · VAI1
DanderydMasimo Sweden AB
FEI 3005450689
Devices2Mar 19, 2015 · NAI—
EskilstunaStille Surgical Ab
FEI 3006486433
Devices2Aug 21, 2013 · NAI—
EslovBioGaia Production AB
FEI 3010052960
Food/Cosmetics2Sep 11, 2019 · NAI3
EslovOrkla Foods Sverige
FEI 3004290080
Food/Cosmetics1Sep 10, 2019 · NAI—
FalkopingAtria Supply AB Falkoping
FEI 3010057309
Food/Cosmetics1Oct 14, 2014 · VAI—
FalkopingAtria Sverige AB
FEI 3011088361
Food/Cosmetics1Oct 14, 2014 · NAI—
FalkopingTotteGott AB (Falkoping facility)
FEI 3010341646
Food/Cosmetics1Aug 21, 2013 · VAI5
FilipstadBarilla Sverige AB
FEI 3004299319
Food/Cosmetics1Aug 20, 2013 · NAI—
GetingeHAFI Hallands Fruktindustri AB
FEI 1000175092
Food/Cosmetics1Sep 9, 2024 · NAI—
GoteborgNEOSS AB
FEI 3017399129
Devices1Jun 27, 2023 · VAI2
GoteborgNobel Biocare
FEI 3002807692
Devices1Apr 1, 2010 · NAI—
GoteborgVitrolife Sweden AB
FEI 3003995932
Devices1Feb 18, 2010 · NAI—
GoteborgXVIVO PERFUSION AB
FEI 3007710603
Devices1Feb 25, 2016 · NAI—
GotenborgGestenco International AB
FEI 3004109528
Devices1Jun 13, 2012 · NAI—
GothenburgSwedish Match North Europe
FEI 3011373995
Tobacco1Apr 14, 2015 · VAI—
GustavsbergAstaReal AB
FEI 3013330737
Food/Cosmetics1Aug 22, 2019 · NAI—
HaboMedicaNatumin AB
FEI 3009378968
Food/Cosmetics2May 20, 2019 · NAI3
HagerstenAB RAHMS KEXFABRIK
FEI 3009768123
Food/Cosmetics1Oct 17, 2014 · VAI10
HalleforsDelMat AB
FEI 3007154093
Food/Cosmetics1Oct 20, 2014 · NAI—
HalmstadRemeda AB
FEI 3013300766
Devices1Sep 14, 2023 · VAI1
HandenForetagsfrukt I Europa AB
FEI 3010243909
Food/Cosmetics1Oct 29, 2014 · NAI—
HarslovToxicon AB
FEI 3021279130
Drugs2Jun 26, 2025 · VAI—
HelsingborgAbdon Finax
FEI 3002331164
Food/Cosmetics1Oct 7, 2014 · NAI—
HelsingborgMcNeil AB
FEI 1000409186
Drugs5Feb 27, 2025 · VAI—
HorbyAtos Medical AB
FEI 3002806269
Devices2Sep 12, 2013 · NAI—
HuddingeNaslund Medical Ab
FEI 3008191247
Devices1May 3, 2023 · NAI—
JarfallaPerimed AB
FEI 3003244961
Devices2Jan 29, 2025 · NAI—
JonkopingBubs Godis
FEI 3009943698
Food/Cosmetics1May 16, 2019 · VAI1
JonkopingKitron AB
FEI 3009834076
Devices2Nov 10, 2022 · VAI13
KagerodBarry Callebaut Sw
FEI 3005948809
Food/Cosmetics1Aug 23, 2013 · NAI—
KallbyGunnar Dafgard AB
FEI 3007544229
Food/Cosmetics1Apr 21, 2023 · NAI—
KarlshamnAAK Sweden AB
FEI 3007981449
Drugs3May 11, 2023 · VAI—
KarlskogaCambrex Karlskoga AB
FEI 3001686607
Drugs5May 24, 2024 · VAI—
KarlskogaMeribel Pharma Karlskoga AB
FEI 3004713444
Drugs5Aug 29, 2025 · VAI—
KarlskogaNOBEL BIOCARE AB, PRODUKTION
FEI 3002807693
Devices2Oct 27, 2011 · NAI—
KarlstadAurena Laboratories AB
FEI 3004080052
Drugs2Sep 13, 2019 · VAI9
KimstadLantmannen Biorefineries AB
FEI 3008722075
Food/Cosmetics1Oct 22, 2014 · VAI1
KistaDirect Healthcare Group Sverige AB
FEI 3009481053
Devices1Jun 4, 2015 · VAI5
KladesholmenKladesholmen Seafood AB
FEI 3004273265
Food/Cosmetics2Sep 19, 2019 · NAI6
KlippanEssentia Protein Solutions AB
FEI 3012007827
Food/Cosmetics1May 24, 2019 · NAI—
KnivstaPharma Systems AB
FEI 3005519819
Devices1Feb 6, 2014 · NAI—
KopingMilena (Lena) Nicol, PI
FEI 3008203306
Drugs1Mar 25, 2010 · VAI—
KristianstadKristianstads Mejeriet AB
FEI 3009990486
Food/Cosmetics1Oct 10, 2014 · VAI—
KristianstadSkanemejerier Ek For
FEI 1000281116
Food/Cosmetics1Oct 10, 2014 · NAI—
KumlaLegosan AB
FEI 3005488660
Food/Cosmetics2May 15, 2019 · NAI4
KungalvGoteborgs Kex
FEI 3004313527
Food/Cosmetics1Sep 4, 2013 · NAI—
KungalvSwedish Match North Europe
FEI 3011373997
Tobacco1Apr 16, 2015 · VAI—
Kungens KurvaApotek Produktion & Laboratorier AB
FEI 3004967053
Drugs5Apr 28, 2022 · NAI6
KungsangenFresenius Kabi (Brunna Facility) AB
FEI 3002996654
Drugs5Sep 21, 2023 · VAI—
KungshamnLeroy Smogen Seafood AB
FEI 3009893921
Food/Cosmetics1Apr 26, 2023 · NAI—
KungshamnOrkla Foods Sweden AB
FEI 3004251934
Food/Cosmetics2Sep 16, 2019 · NAI—
LaholmLantmannen Cerealia Laholm
FEI 3010167205
Food/Cosmetics2May 9, 2019 · VAI5
LeksandLeksands Knackebrod AB
FEI 3006335077
Food/Cosmetics2Aug 28, 2019 · VAI5
Lilla EdetEmanuel Andren Gastronomy AB
FEI 3008805764
Food/Cosmetics1Sep 4, 2013 · NAI—
LimhamnPolyPeptide Laboratories (Sweden) AB
FEI 3002807004
Drugs5Jan 23, 2025 · VAI—
LimhamnRechon Life Science AB
FEI 3002806978
Devices; Drugs7Sep 6, 2024 · OAI—
LinkopingAlcontrol Laboratories
FEI 3010403933
Drugs1Dec 3, 2013 · VAI—
LinkopingSectra AB
FEI 3001104292
Devices1Aug 29, 2012 · VAI—
LjungGasene Mejeriforening
FEI 3004380357
Food/Cosmetics; Veterinary1Sep 16, 2024 · NAI—
LjungsbroCloetta Produktion Sverige AB
FEI 3009946514
Food/Cosmetics1Aug 28, 2013 · VAI3
LuleaALS Scandinavia AB
FEI 3007165135
Drugs5Oct 10, 2024 · VAI—
LuleaLiko AB
FEI 3000230206
Devices1Sep 5, 2024 · NAI—
LundBone Support AB
FEI 3005304945
Devices3Sep 17, 2015 · NAI3
LundCamurus Ab
FEI 3002912166
Devices1Jun 3, 2016 · VAI2
LundCellavision AB
FEI 3003630693
Devices2Nov 16, 2016 · NAI—
LundGambro Lundia AB
FEI 3002807039
Devices3Jan 26, 2017 · NAI—
LundJolife AB
FEI 3005445717
Devices2Jul 2, 2014 · NAI—
LundProbi AB
FEI 3005172456
Food/Cosmetics1May 27, 2019 · NAI—
LundProstalund AB
FEI 3002591507
Devices1Apr 17, 2009 · NAI—
LysekilDomstein Foods
FEI 3011096760
Food/Cosmetics1Oct 17, 2014 · VAI—
LysekilMarenor Lysekil AB
FEI 3010024291
Food/Cosmetics2Apr 25, 2023 · NAI—
MalmkopingSwitsbake Int AB
FEI 3009941927
Food/Cosmetics1Aug 23, 2013 · NAI—
MalmoApotek Produktion & Laboratorier AB
FEI 3002806290
Drugs5Feb 29, 2024 · VAI—
MalmoARJOHUNTLEIGH AB
FEI 3002806395
Devices1Feb 7, 2013 · NAI—
MalmoBiora AB
FEI 3002806508
Devices1Sep 3, 2014 · NAI—
MalmoMagle Chemoswed AB
FEI 3000181361
Drugs3Dec 12, 2019 · VAI—
MalmoPagen AB
FEI 1000175690
Food/Cosmetics1Aug 21, 2013 · NAI—
MalmoSaturnus AB, Bronsyxegatan
FEI 3009982299
Food/Cosmetics1Sep 6, 2024 · NAI—
MalmoSever Pharma Solutions
FEI 3004620701
Drugs5May 12, 2023 · VAI1
MalmoSvar Life Science AB
FEI 3007610287
Devices2Apr 26, 2018 · NAI7
MariestadParts Precision Sweden AB
FEI 3011385607
Devices1May 12, 2015 · VAI—
MjolbyASM Foods AB
FEI 3004268609
Food/Cosmetics1Sep 4, 2013 · NAI—
MjolbyCenova AB
FEI 3005216725
Devices2May 8, 2025 · VAI4
MolndalAbigo Medical AB
FEI 3004017406
Devices1Jan 30, 2018 · NAI—
MolndalDENTSPLY Implants (a Division of DENTSPLY IH AB)
FEI 3002806429
Devices2Feb 21, 2013 · VAI3
MolndalIntegrum Ab
FEI 3011386779
Devices2Sep 8, 2022 · VAI3
MolndalNeoventa Medical AB
FEI 3005011303
Devices2Feb 10, 2011 · VAI10
MolndalNidacon International
FEI 3004848623
Devices1May 28, 2015 · NAI—
MolndalWellspect HealthCare (Division of DENTSPLY IH AB)
FEI 3009632672
Devices1Aug 13, 2015 · NAI—
MolnlyckeBreas Medical AB
FEI 3003244771
Devices3Aug 10, 2022 · VAI3
MolnlyckeNeoss Ab
FEI 3008517673
Devices1Sep 22, 2010 · VAI2
NackaMedical Vision Ab
FEI 3003647329
Devices1Feb 15, 2018 · NAI—
NorrkopingWhirlpool Sweden
FEI 1000251176
Devices1Apr 6, 2009 · VAI—
NyakerAB Nyakers Pepparkakor
FEI 3004257679
Food/Cosmetics1Aug 27, 2013 · VAI4
OrkelljungaContinental Bakeries North Europe AB
FEI 3004258180
Food/Cosmetics1Aug 30, 2013 · NAI—
OrnskoldsvikSanmina-SCI AB
FEI 3004201275
Devices2Dec 13, 2013 · OAI2
OstersundLaser Nova AB
FEI 3006151021
Devices1Feb 2, 2023 · VAI5
RonnangKladesholmen Seafood AB
FEI 3013223414
Food/Cosmetics1Sep 20, 2019 · NAI—
SeskaroNorrmejerier/ Anaset Warehouse
FEI 3011114467
Food/Cosmetics1Oct 23, 2014 · NAI—
SkaraElos Medtech Skara AB
FEI 3012416874
Devices2Aug 31, 2023 · NAI4
SkarpnackAroma Konfektyrfabriken Aroma
FEI 3008606094
Food/Cosmetics1Aug 28, 2013 · VAI3
SkovdeCandy Logistics AB
FEI 3010460731
Food/Cosmetics1Aug 19, 2013 · NAI—
SkovdeTotteGott AB (Skovde facility)
FEI 3007554504
Food/Cosmetics1Aug 21, 2013 · VAI4
SodertaljeAstraZeneca AB
FEI 3002806411
Drugs9Mar 19, 2026 · VAI2
SodertaljeAstraZeneca AB
FEI 3003342394
Devices; Drugs10Dec 12, 2025 · VAI—
SollentunaMikrolab Stockholm AB
FEI 3002806287
Drugs4Mar 6, 2025 · VAI—
SollentunaMKL DIAGNOSTICS AB
FEI 3009335508
Devices1Mar 25, 2014 · OAI—
SolnaCepheid Ab
FEI 3009613136
Devices2Mar 15, 2017 · NAI4
SolnaMaquet Critical Care AB
FEI 3002808128
Devices2Sep 26, 2019 · VAI4
SolnaOrkla Care AB
FEI 3000182940
Devices2Jun 11, 2015 · NAI—
SolnaSectra Mamea AB
FEI 3005066877
Devices1Oct 9, 2008 · VAI—
SolnaSonesta Medical AB
FEI 3010496070
Devices2Jun 7, 2023 · OAI14
SpangaBoule Medical AB
FEI 3004008703
Devices3Feb 19, 2026 · NAI3
StaffanstorpDC ELEKTRONIK AB
FEI 3009228519
Devices1Feb 8, 2017 · VAI—
StockholmAbsorber Ab
FEI 3005287147
Biologics1Apr 18, 2013 · VAI—
StockholmAromatic AB
FEI 1000230787
Food/Cosmetics1Aug 22, 2013 · NAI—
StockholmCecilia Friberg, DVM
FEI 3008644332
Veterinary1Dec 7, 2010 · NAI—
StockholmELEKTA SOLUTIONS AB
FEI 3015232217
Devices1May 22, 2025 · VAI3
StockholmEPISURF OPERATIONS AB
FEI 3015341893
Devices1Nov 11, 2025 · VAI—
StockholmJan Bolinder, MD
FEI 3010600232
Devices1Sep 22, 2017 · NAI—
StockholmM Dialysis AB
FEI 3003733874
Devices1Mar 13, 2014 · VAI1
StockholmMedifactia AB
FEI 3015871081
Devices1Nov 14, 2022 · OAI—
StockholmMELOQ AB
FEI 3013687630
Devices1Mar 9, 2023 · VAI6
StockholmNobel Biocare Procera AB
FEI 3003719670
Devices1Apr 1, 2010 · NAI—
StockholmNUVOAIR AB
FEI 3013744763
Devices1Sep 22, 2022 · VAI—
StockholmOctapharma AB
FEI 3005559915
Biologics6Sep 19, 2023 · VAI3
StockholmOlerup SSP AB
FEI 3002522915
Biologics1Jul 7, 2016 · NAI—
StockholmPer Ljungman, MD
FEI 3012180348
Biologics1Apr 29, 2016 · NAI—
StockholmRAYSEARCH LABORATORIES AB
FEI 3007774465
Devices1Nov 17, 2022 · OAI5
StockholmRecipharm Stockhom AB
FEI 3003741149
Drugs2Mar 11, 2014 · VAI1
StockholmSoo Aleman, MD
FEI 3021335565
Drugs2Jan 20, 2026 · NAI—
StockholmSwedish Match North Europe
FEI 3011373848
Tobacco1Apr 17, 2015 · NAI—
StockholmSwedish Orphan Biovitrum AB (Publ)
FEI 3003455777
Biologics; Drugs7Aug 29, 2019 · NAI1
StrangnasAPL Strangnas AB
FEI 3006524831
Drugs3Mar 6, 2025 · VAI—
StrangnasPfizer Health AB
FEI 3003150913
Biologics; Drugs7Mar 6, 2026 · VAI—
SundbybergScibase Ab
FEI 3008285458
Devices2Nov 3, 2022 · NAI1
SvenstavikSamhall AB
FEI 3002808176
Devices1Jun 9, 2023 · OAI6
SvinningeBeauvais Foods A/S
FEI 9241
Food/Cosmetics1Aug 10, 2012 · VAI4
TimmersdalaElos Medtech Timmersdala AB
FEI 3003847101
Devices3Aug 21, 2025 · NAI6
TimraPermobil AB
FEI 3004908349
Devices2Feb 12, 2016 · VAI4
TingsrydTrensums Food AB
FEI 3003450406
Food/Cosmetics1Oct 27, 2014 · NAI—
TollarpOrkla Foods Sverige (Tollarp)
FEI 3004290106
Food/Cosmetics1Apr 18, 2023 · NAI—
TorekovNOLATO MEDITOR AB
FEI 3005979524
Devices1Apr 24, 2025 · NAI—
TorsbyNOTE TORSBY AB
FEI 3011512432
Devices1Jan 11, 2024 · VAI4
TorshallaAroma Konfektyfabriken AB
FEI 3010332772
Food/Cosmetics1Aug 23, 2013 · VAI6
TorshallaStille AB
FEI 3003696170
Devices3Sep 28, 2023 · VAI11
TorslandaAlmondy AB
FEI 3005461228
Food/Cosmetics1Sep 2, 2013 · NAI—
TranasTR Equipment AB
FEI 3002913923
Devices1Dec 7, 2023 · VAI9
TyresoAB Annas Pepparkakor
FEI 3004271546
Food/Cosmetics1Sep 2, 2013 · NAI—
TyresoArta Plast AB
FEI 3002807188
Devices1Nov 13, 2025 · VAI—
UmeaApotek Production & Laboratorier AB
FEI 3003766921
Devices3Mar 2, 2023 · VAI2
Upplands VasbyDirecta AB
FEI 3004586882
Devices1Sep 5, 2019 · VAI3
Upplands VasbyONCOlog Medical QA AB
FEI 3007160904
Devices1Oct 9, 2012 · VAI2
Upplands-VasbyMondelez Sverige Production AB
FEI 3013297497
Food/Cosmetics2Jun 14, 2017 · VAI—
UppsalaAMO Uppsala AB
FEI 3004750704
Devices3Feb 8, 2024 · VAI—
UppsalaApriomed Ab
FEI 3007664053
Devices1Aug 24, 2017 · NAI—
UppsalaBringwell Sverige AB
FEI 3010075565
Food/Cosmetics1Nov 3, 2014 · NAI—
UppsalaC-RAD POSITIONING AB
FEI 3006621300
Devices1Jul 19, 2018 · VAI4
UppsalaCircassia AB
FEI 3008662397
Devices2Feb 18, 2015 · NAI—
UppsalaEurofins Biopharma Product Testing Sweden AB
FEI 3008759559
Drugs; Veterinary4Jun 19, 2024 · VAI6
UppsalaEurofins BioPharma Product Testing Sweden AB
FEI 3008763211
Drugs; Veterinary5Jun 19, 2024 · VAI9
UppsalaFresenius Kabi AB
FEI 3002631703
Devices; Drugs; Veterinary9Jan 24, 2025 · VAI6
UppsalaMIRIS AB
FEI 3013887826
Devices1Feb 15, 2024 · NAI—
UppsalaNovus Scientific Ab
FEI 3010187263
Devices3Jan 23, 2025 · NAI4
UppsalaOasmia Pharmaceutical AB
FEI 3007109392
Veterinary2Mar 3, 2015 · NAI20
UppsalaOrexo AB
FEI 3006143818
Drugs1Apr 25, 2013 · NAI—
UppsalaPhadia Ab
FEI 3002807876
Devices1Aug 18, 2011 · NAI—
UppsalaQ-Med AB
FEI 3003347293
Devices9Jan 19, 2023 · NAI—
UppsalaRecipharm Uppsala AB
FEI 1000171246
Drugs4Apr 17, 2024 · VAI1
UppsalaScandiDos AB
FEI 3005596716
Devices1Jul 12, 2018 · VAI4
UppsalaSenzime AB
FEI 3016490024
Devices1Jan 18, 2024 · VAI3
UppsalaSt. Jude Medical Systems AB
FEI 3002807976
Devices2Sep 12, 2013 · NAI—
UppsalaStatens Verinarmedicinska Anstalt (SVA)/National Veterinary
FEI 3007259492
Drugs1Jan 16, 2009 · VAI—
VadstenaFredriksons Verkstad AB
FEI 3009709474
Devices1Oct 12, 2012 · VAI1
VaggerydFogless International AB
FEI 3014054118
Devices1Aug 28, 2025 · VAI3
VarbergWarberg Candy Group Ab
FEI 3006052808
Food/Cosmetics1Aug 28, 2013 · NAI—
VasterasTOUL MEDITECH AB
FEI 3012992602
Devices1Feb 27, 2025 · VAI4
Vastra FrolundaHertART ApS
FEI 3008524469
Devices3Aug 28, 2023 · NAI10
VaxjoArcoma AB
FEI 3002675731
Devices2Jun 27, 2013 · NAI1
VaxjoGetinge Disinfection Ab
FEI 3000231474
Devices1Sep 19, 2013 · NAI—
VellingeScandi Candy AB
FEI 3004284387
Food/Cosmetics1Sep 4, 2024 · NAI—
VimmerbyAbro Bryggeri AB
FEI 3007000407
Food/Cosmetics1Aug 20, 2019 · VAI—
VimmerbyProcordia Food AB Frodingemejeriet
FEI 1000151762
Food/Cosmetics1Aug 29, 2013 · NAI—
VinningaPrototal-Pds Ab
FEI 3010526986
Devices1Aug 29, 2018 · NAI—
YstadOrifice Medical AB
FEI 3002807820
Devices; Drugs2Sep 17, 2015 · NAI—

Alphabetical order — this site ranks no firm. Inspections from fiscal year 2009 to 2026; the classification is the FDA's (NAI no action indicated, VAI voluntary action indicated, OAI official action indicated). Select a firm for every inspection, the posted Form 483 observations and any compliance action. How to read this.