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Tuesday, December 3, 2024

FDA conducted third highest number of inspections on device companies in Wisconsin during 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In 2023, 22 device companies received 22 FDA inspections in Wisconsin, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Wisconsin, equalling 6.4% of all inspections in 2023.

Of all the Wisconsin companies involved in the device sector, Daniels Manufacturing Operations, Inc. received the most citations from the FDA in 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Top 10 FDA Inspections by Number of Actions Indicated in Wisconsin During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products11----
Colors and Cosmetics Technology6----
Compliance: Devices7121
Drug Quality Assurance141
Food Composition, Standards, Labeling and Econ1112--
Foodborne Biological Hazards142342
Monitoring of Marketed Animal Drugs, Feed, and Devices77211
Postmarket Assurance: Devices12----
Technical Assistance: Food and Cosmetics192--

ORGANIZATIONS IN THIS STORY

Village of HartlandVillage of GilmanCity of Chippewa FallsCambridge VillageVillage of Blue RiverCity of VeronaCity of River FallsCity of St. FrancisCity of StanleyVillage of AthensVillage of Pleasant PrairiePorterfieldVillage of ClymanVillage of Union CenterVillage of HolmenVillage of HancockCity of New HolsteinVillage of HixtonAllentonVillage of SlingerVillage of LenaVillage of North FreedomCity of ViroquaCity of WhitewaterVillage of BonduelCity of ThorpVillage of Gays MillsCity of AppletonVillage of Blue MoundsVillage of NecedahCity of Wisconsin RapidsVillage of ColemanTown of FreedomMapleCity of Beaver DamCity of WestbyVillage of EttrickVillage of BlanchardvilleCity of MadisonCity of New BerlinCity of KewauneeVillage of CambriaCity of WaupunVillage of Menomonee FallsHelenvilleVillage of GenoaVillage of CampbellsportCity of MedfordVillage of BoycevilleVillage of Elk MoundVillage of SturtevantVillage of MasonCity of BrodheadCity of MonroeVillage of MuscodaCity of SheboyganCity of AugustaCity of MarshfieldCity of HoriconVillage of WaldoCity of Sturgeon BayCity of Eau ClaireCity of LA CrosseVillage of MelroseJudaCity of JanesvilleVillage of HilbertArkansawVillage of StratfordVillage of DenmarkCity of WausauCity of RacineGermantownCity of Lake GenevaVillage of DorchesterCity of EvansvilleVillage of TaylorVillage of OntarioVillage of JacksonCity of JuneauCity of New LondonVillage of CashtonCity of RhinelanderVillage of SpencerCity of Black River FallsCity of MiddletonVillage of KnappCity of PlattevilleWatertownCity of BurlingtonCity of Green BayCity of TomahawkCity of ManitowocCity of AbbotsfordVillage of CrivitzHumbirdVillage of Coon ValleyVillage of Mount HorebCity of MarinetteCity of Oconto FallsCity of De PereCity of WauwatosaCity of MondoviCity of KaukaunaCity of SchofieldCity of LancasterVillage of McFarlandCity of PlymouthVillage of Little ChuteCity of SpoonerCity of GreenwoodCity of Fort AtkinsonCity of AshlandVillage of EllsworthCity of Fond Du LacVillage of ValdersCity of Oak CreekCity of ElkhornVillage of Sister BayCity of OwenVillage of DresserVillage of PardeevilleGreenleafCity of BarabooVillage of BangorCity of MenomonieVillage Of LannonFountain City CityVillage Of RichfieldCity Of ElroyVillage Of OsceolaCity Of PortageCity Of TomahVillage Of North Fond Du LacCity of MiltonCity Of Prairie Du ChienVillage Of Cedar GroveCity Of Sheboygan FallsVillage Of CadottCity Of NeenahVillage Of FredericVillage Of MonticelloVillage Of DarienCity Of West AllisCity of ChiltonCity Of MosineeSauk CityCity of BarronCity Of CumberlandVillage Of DickeyvilleMinocquaCity Of Two RiversCity Of ColumbusVillage Of PloverVillage Of KendallCity Of StoughtonVillage Of StockholmWisconsin-Stevens PointCity Of Neillsville

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