FDA inspections of firms in Durham, NC
165 firms in Durham were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 101 NAI, 60 VAI, 4 OAI. Main product types: Devices (70), Drugs (51), Food/Cosmetics (28).
| Firm | Product types | Inspections | Latest inspection | 483 observations posted |
|---|---|---|---|---|
| 410 Medical, Inc. FEI 3012969104 | Devices | 2 | Aug 16, 2024 · NAI | 2 |
| 623 Medical LLC FEI 3018382913 | Devices | 1 | Aug 10, 2023 · NAI | — |
| Abraxis Bioscience Llc FEI 3008579542 | Drugs | 1 | Sep 15, 2010 · VAI | — |
| Accord Healthcare, Inc. FEI 3007518432 | Drugs | 4 | Jan 19, 2017 · NAI | 3 |
| Aegis Surgical Limited FEI 3011528315 | Devices | 2 | Oct 22, 2019 · NAI | — |
| Airgas USA, LLC FEI 1000111992 | Devices | 2 | Mar 11, 2016 · NAI | — |
| Aldagen, Inc. FEI 3006215860 | Devices | 1 | Sep 18, 2009 · VAI | 8 |
| Allscripts Healthcare Solutions, LLC FEI 3009662297 | Devices | 2 | May 11, 2017 · NAI | — |
| Almac Clinical Services, LLC. FEI 3003501234 | Drugs | 3 | Jun 8, 2016 · NAI | 2 |
| American Red Cross Blood Svcs FEI 1075944 | Biologics | 6 | Oct 16, 2023 · VAI | 2 |
| Annick Desjardins, MD FEI 3030039615 | Biologics | 1 | May 8, 2024 · NAI | — |
| Areeg Hassan El-Gharbawy, MD, DSc FEI 3042640409 | Biologics | 1 | May 1, 2026 · NAI | — |
| Aurolife Pharma LLC FEI 3014028588 | Drugs | 1 | Aug 26, 2022 · VAI | — |
| Avioq, Inc. FEI 3008376326 | Biologics; Devices | 5 | Dec 5, 2023 · VAI | 3 |
| Avista Pharma Solutions, Inc. FEI 3011795391 | Drugs | 4 | Jul 3, 2025 · NAI | — |
| Baebies Inc FEI 3011240982 | Devices | 1 | Apr 27, 2017 · NAI | — |
| BAVARIAN NORDIC INC FEI 3023990823 | Biologics | 1 | Feb 6, 2025 · NAI | — |
| BD FEI 3004173866 | Devices | 2 | Aug 7, 2019 · NAI | — |
| Bioaesthetics Corporation FEI 3016130529 | Biologics | 2 | Oct 3, 2024 · NAI | — |
| BioAgilytix Labs LLC FEI 3007929739 | Biologics; Drugs | 4 | Jul 10, 2026 · VAI | — |
| Biocryst Pharmaceuticals, Inc. FEI 3009713274 | Drugs | 2 | May 5, 2017 · NAI | — |
| bioMerieux, Inc. FEI 3002769706 | Devices | 4 | Apr 10, 2017 · VAI | 16 |
| BIORESOURCE INTERNATIONAL INC FEI 3012714567 | Veterinary | 1 | Jul 26, 2024 · NAI | — |
| Bioventus LLC FEI 3009595577 | Devices | 1 | Jun 10, 2014 · NAI | — |
| Brenntag Global Marketing, Llc FEI 3012387830 | Food/Cosmetics | 1 | Feb 22, 2021 · NAI | — |
| Brenntag Mid-South Inc FEI 3004261101 | Food/Cosmetics | 2 | Jan 11, 2018 · NAI | — |
| Bull City Provisions FEI 3007259298 | Food/Cosmetics | 1 | Feb 24, 2016 · VAI | 3 |
| Burt's Bees Inc. FEI 3003234533 | Drugs; Food/Cosmetics | 2 | Aug 26, 2015 · NAI | 15 |
| California Cryobank LLC FEI 3028071571 | Biologics | 1 | Sep 13, 2024 · NAI | — |
| Camelo A. Milano, MD - Clinical Investigator FEI 3014151632 | Devices | 1 | Mar 28, 2018 · NAI | — |
| Cancer Diagnostics Inc. FEI 3007496191 | Devices | 4 | Jul 23, 2026 · VAI | 16 |
| Cardinal Health Inc FEI 3004250121 | Food/Cosmetics | 1 | Sep 14, 2023 · NAI | — |
| Carsgen Therapeutics Corporation FEI 3020703259 | Biologics | 1 | Sep 6, 2024 · NAI | — |
| Cary Robertson, MD FEI 3010825141 | Devices | 1 | Aug 8, 2014 · NAI | — |
| Chi Dang Hornik, Pharm.D FEI 3037282723 | Drugs | 1 | May 23, 2025 · VAI | — |
| Chimerix Inc FEI 3004414612 | Drugs | 1 | Mar 14, 2025 · NAI | — |
| Christopher Hoimes, M.D. FEI 3031824072 | Drugs | 1 | Oct 2, 2024 · VAI | 1 |
| Concept Food Service Distributors, Inc. FEI 3009179418 | Food/Cosmetics | 1 | Aug 5, 2011 · VAI | — |
| Concept Food Services Distributors, Inc. FEI 2000012791 | Food/Cosmetics | 5 | Aug 3, 2023 · VAI | 32 |
| Confidant Inc. FEI 3005175625 | Devices | 1 | Sep 15, 2009 · NAI | — |
| Corning Incorporated Discovery Labware FEI 1000110807 | Devices | 3 | Oct 30, 2019 · NAI | 1 |
| Counter Culture Coffee FEI 3004341409 | Food/Cosmetics | 1 | Sep 17, 2014 · VAI | — |
| Courtney R. Goodwin, M.D., Ph.D. FEI 3042755158 | Devices | 1 | Feb 13, 2026 · NAI | — |
| Covance by Labcorp FEI 3015592983 | Drugs | 1 | May 20, 2021 · VAI | 1 |
| Cristina Gasparetto, M.D. FEI 3027566085 | Drugs | 1 | Sep 29, 2023 · NAI | — |
| CSL Plasma Inc. FEI 3009495839 | Biologics | 3 | Feb 19, 2019 · NAI | — |
| Data Spectrum Corp. FEI 3002989475 | Devices | 2 | Feb 7, 2013 · NAI | — |
| David Rizzieri, MD FEI 3017232419 | Drugs | 1 | Apr 13, 2021 · NAI | — |
| David S Huber Pipes FEI 3013853718 | Tobacco | 2 | May 30, 2024 · NAI | — |
| Debra L. Sudan, MD FEI 3017568641 | Devices | 1 | Jul 21, 2021 · NAI | — |
| Deep Blue Medical Advances Inc. FEI 3017492634 | Devices | 1 | May 18, 2023 · NAI | — |
| Dewhirst, Mark W. FEI 3007048082 | Devices | 1 | Aug 27, 2009 · VAI | 6 |
| Dimmig, Thomas A FEI 3007221494 | Devices | 1 | Dec 15, 2009 · VAI | 1 |
| Drug Safety Alliance FEI 3008581317 | Drugs | 3 | Jun 24, 2016 · NAI | — |
| Duke Clinical Research Institute FEI 3006738414 | Devices; Drugs | 4 | Jan 17, 2019 · NAI | 2 |
| Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell Laboratory FEI 3002663011 | Biologics | 5 | Nov 22, 2024 · NAI | — |
| Duke University Health System IRB FEI 1045114 | Biologics; Devices; Drugs | 5 | Sep 11, 2025 · NAI | — |
| Duke University Medical Center Duke Hospital North FEI 1074242 | Biologics | 8 | May 9, 2024 · NAI | — |
| Durham Exchange Club Industries Inc (DECI) FEI 3000328994 | Devices; Tobacco | 4 | Sep 23, 2025 · NAI | 2 |
| Durham VA Medical Center IRB FEI 1037908 | Devices; Drugs | 3 | Dec 10, 2024 · NAI | — |
| Edgardo R. Parrilla Castellar M.D. FEI 3033553051 | Devices | 1 | Feb 25, 2025 · NAI | — |
| El Camino Mexican Foods Distribu FEI 3006594843 | Food/Cosmetics | 2 | Oct 27, 2020 · NAI | 1 |
| Encube Ethicals Inc FEI 3015216825 | Drugs | 1 | Jan 23, 2025 · NAI | — |
| Epiphany Craft Malt FEI 3011895579 | Food/Cosmetics | 1 | May 16, 2023 · NAI | — |
| F & D International Corporation FEI 3004969351 | Food/Cosmetics | 1 | Aug 25, 2016 · NAI | — |
| Ferrell Industries Inc. FEI 3010576928 | Food/Cosmetics | 4 | Mar 26, 2025 · VAI | 1 |
| FUJIFILM Healthcare Americas Corporation FEI 3004972322 | Devices | 1 | Nov 8, 2017 · NAI | — |
| Full Power AED LLC FEI 3013540012 | Devices | 1 | Dec 14, 2018 · VAI | 8 |
| G & G Gourmet Inc. FEI 3004146629 | Food/Cosmetics | 3 | Jun 1, 2021 · NAI | 8 |
| G. Charles Hughes, MD FEI 3010444576 | Devices | 1 | Oct 17, 2013 · VAI | 1 |
| Gary E. Archer, Ph.D. FEI 3014025248 | Biologics | 1 | May 16, 2018 · NAI | — |
| GlaxoSmithKline LLC FEI 1035048 | Drugs | 11 | Aug 16, 2024 · NAI | — |
| Gorbec Pharmaceutical Services Inc. FEI 3006405455 | Devices; Drugs | 3 | Jan 20, 2011 · NAI | — |
| Gregory Fleming, MD FEI 3011756804 | Devices | 1 | Dec 10, 2015 · NAI | — |
| Grichnik, James FEI 3007714725 | Devices | 1 | Aug 27, 2009 · NAI | — |
| Harry Erba, MD FEI 3017230712 | Drugs | 1 | Apr 13, 2021 · NAI | — |
| Health Decisions, Inc. FEI 3007758286 | Devices | 1 | Jan 25, 2018 · NAI | — |
| HEMO BIOSCIENCE INC FEI 3017237798 | Biologics | 1 | Jul 30, 2026 · NAI | — |
| HEMOSONICS LLC FEI 3014240198 | Devices | 1 | Aug 20, 2021 · VAI | 1 |
| HonorBridge FEI 3003651458 | Biologics | 6 | Apr 23, 2026 · NAI | — |
| Horizon Coach Lines FEI 3009996188 | Food/Cosmetics | 1 | Oct 16, 2014 · NAI | — |
| Horner International, Inc. FEI 2000043063 | Food/Cosmetics | 3 | May 28, 2026 · NAI | — |
| Humacyte Global, Inc FEI 3014294024 | Biologics | 2 | Feb 12, 2026 · NAI | — |
| HyperBranch Medical Technology, Inc. FEI 3005920920 | Devices | 4 | Jun 15, 2016 · NAI | — |
| InnAVasc Medical, Inc. FEI 3015376580 | Devices | 1 | Jun 6, 2019 · VAI | 1 |
| IQVIA FEI 1000111052 | Devices; Drugs | 7 | Jan 30, 2019 · NAI | — |
| IQVIA Biotech FEI 3018751062 | Drugs | 4 | Jan 27, 2025 · NAI | — |
| J'ellen Jams FEI 3012758807 | Food/Cosmetics | 1 | Jul 29, 2021 · VAI | 1 |
| J. Kevin Harrison, MD FEI 3010377485 | Devices | 1 | Nov 8, 2013 · NAI | — |
| Jacob N. Schroder, MD FEI 3013766546 | Devices | 1 | Feb 28, 2018 · NAI | — |
| Jad Walters, Ph.D. FEI 3027331360 | Devices | 2 | Nov 7, 2024 · NAI | — |
| James Nunley MD FEI 3005692802 | Devices | 1 | Jan 20, 2017 · NAI | — |
| Joanne Kurtzberg MD FEI 3016506339 | Biologics | 2 | Jun 30, 2022 · VAI | — |
| John Sleasman, MD FEI 3014671661 | Biologics | 1 | Dec 14, 2018 · NAI | — |
| Jonathan Riboh, M.D. FEI 3015468079 | Devices | 1 | Sep 12, 2019 · NAI | — |
| Joseph O Moore MD FEI 1000111988 | Drugs | 1 | May 6, 2009 · VAI | 2 |
| KaryoLogic Inc FEI 3032019264 | Veterinary | 1 | Dec 19, 2025 · VAI | 9 |
| KBI Biopharma, Inc. FEI 3004638264 | Drugs | 5 | Apr 1, 2026 · VAI | — |
| KLG Candies, LLC FEI 3010517236 | Food/Cosmetics | 2 | Mar 18, 2025 · NAI | 3 |
| Lalilab Inc FEI 3003345305 | Food/Cosmetics | 3 | May 15, 2024 · NAI | — |
| Leica Microsystems NC Inc. FEI 3006809695 | Devices | 2 | May 22, 2018 · NAI | — |
| LNHC Inc FEI 3035364814 | Drugs | 2 | Jan 16, 2026 · VAI | — |
| Lodge, Andrew J. MD FEI 3006287113 | Devices | 1 | Feb 3, 2010 · NAI | — |
| Lukes, Andrea, M.D. FEI 3007539686 | Drugs | 1 | Jul 2, 2009 · NAI | — |
| Madhav Swaminathan MD FEI 3015678940 | Biologics | 1 | Oct 4, 2019 · NAI | — |
| Mani Daneshmand FEI 3014534494 | Devices | 1 | Aug 31, 2018 · NAI | — |
| Mark Delegge, M.D. FEI 3030582530 | Devices | 1 | Aug 9, 2024 · NAI | — |
| Matthew Galen Hartwig, M.D. FEI 3017984911 | Drugs | 1 | Jun 17, 2021 · NAI | — |
| Matthew R. Kappus, M.D. FEI 3029809059 | Drugs | 1 | Jan 11, 2024 · NAI | — |
| Maymom LLC FEI 3010196750 | Devices | 1 | Sep 16, 2014 · NAI | — |
| Med-El Corporation FEI 3003370917 | Devices | 2 | Dec 17, 2021 · NAI | — |
| Medical Specialties Inc FEI 3003434195 | Devices | 1 | May 27, 2015 · NAI | — |
| Medline Industrials Inc FEI 1000111206 | Devices | 1 | Jun 6, 2012 · NAI | — |
| MedPharm Manufacturing Services LLC FEI 3004570125 | Drugs | 6 | Nov 7, 2025 · NAI | — |
| Merck Sharp & Dohme LLC FEI 3006525584 | Biologics | 5 | Jun 12, 2024 · NAI | 10 |
| Merck Teknika LLC FEI 1039284 | Biologics | 6 | Nov 27, 2024 · VAI | 6 |
| Milano, Carmelo A FEI 3007441384 | Devices | 1 | May 8, 2009 · NAI | — |
| Momen M. Wahidi, M.D. FEI 3014270236 | Devices | 1 | May 23, 2018 · NAI | — |
| Mp Pharma Services Inc FEI 3012291107 | Drugs | 2 | Aug 30, 2024 · NAI | — |
| Myocardial Solutions Inc. FEI 3006015847 | Devices | 2 | Apr 23, 2025 · NAI | 2 |
| Newrest RDU LLC FEI 3014207070 | Food/Cosmetics | 2 | Apr 15, 2025 · NAI | — |
| Novartis Innovative Technologies Inc. FEI 3015404862 | Biologics | 1 | Jan 26, 2024 · VAI | 2 |
| Novella Clinical FEI 3003590912 | Devices | 1 | Mar 3, 2010 · NAI | — |
| Novo Nordisk Pharmaceutical Industries LP FEI 3016799712 | Drugs | 4 | Jul 30, 2025 · NAI | — |
| OpAns, LLC FEI 3006795769 | Drugs | 5 | Jan 24, 2024 · NAI | — |
| Patty and Dave dba Sweet Janes Bakery LLC FEI 1000132193 | Food/Cosmetics | 2 | Nov 2, 2017 · VAI | 3 |
| PETNET Solutions, Inc. FEI 3007283835 | Drugs | 4 | Jan 4, 2018 · NAI | — |
| Photonicare Inc FEI 3016597890 | Devices | 1 | Aug 25, 2023 · VAI | 3 |
| Priovant Therapeutics Inc. FEI 3042030217 | Drugs | 1 | May 1, 2026 · NAI | — |
| Priya S Kishnani, MD FEI 3005475395 | Drugs | 1 | Jan 22, 2021 · NAI | — |
| Ralph A. Liebelt, M.D. FEI 3004989093 | Devices | 1 | Aug 21, 2019 · NAI | — |
| Ready, Neal Md FEI 3008569840 | Devices | 1 | Feb 4, 2011 · VAI | 1 |
| Research Triangle Institute IRB FEI 1046518 | Biologics; Devices; Drugs | 3 | Jan 23, 2026 · NAI | — |
| restor3d Inc. FEI 3014833750 | Devices | 2 | Jun 14, 2024 · VAI | 10 |
| Sarah H. Lisanby, M.D. FEI 3005170908 | Devices | 1 | Oct 29, 2012 · VAI | 6 |
| Scott Kollins, Ph.D. FEI 3011297988 | Drugs | 1 | Jun 20, 2017 · NAI | — |
| Seal The Seasons, Inc FEI 3009214952 | Food/Cosmetics | 1 | Aug 21, 2013 · NAI | — |
| Seneca Devices Inc FEI 3018115441 | Devices | 1 | May 7, 2025 · NAI | — |
| Simply Flavors Collection, LLC FEI 3007217337 | Food/Cosmetics | 2 | Jun 10, 2025 · NAI | — |
| Simply Fresh Inc. FEI 3010508809 | Food/Cosmetics | 1 | Aug 27, 2009 · VAI | 3 |
| SpringWorks Therapeutics, Inc. FEI 3026006210 | Drugs | 1 | Mar 31, 2023 · VAI | 1 |
| SpringWorks Therapeutics, Inc. FEI 3030400736 | Drugs | 1 | Jan 8, 2026 · NAI | — |
| Stephanie Hastings, PhD FEI 3021245703 | Devices | 1 | Apr 28, 2022 · NAI | — |
| Steris Corporation FEI 3016271578 | Devices | 1 | Apr 1, 2025 · NAI | — |
| Steven A. Olson, MD FEI 3013689164 | Devices | 1 | Oct 27, 2017 · NAI | — |
| Steven M. Anderson, PhD FEI 3011976945 | Devices | 1 | May 19, 2016 · NAI | — |
| Sundy, John, M.D. FEI 3007310483 | Drugs | 1 | Feb 13, 2009 · NAI | — |
| Synthon Pharmaceuticals, Inc FEI 3001238189 | Drugs | 4 | May 18, 2012 · VAI | 3 |
| Team Foods USA, Inc FEI 3027390879 | Food/Cosmetics | 1 | Sep 8, 2026 · NAI | — |
| Teleflex Medical FEI 3004943382 | Devices | 2 | Jan 11, 2013 · NAI | 1 |
| The Blakemere Company FEI 3011410868 | Food/Cosmetics | 1 | Mar 24, 2017 · VAI | 2 |
| The North Carolina Mutual Drug Company FEI 1014761 | Drugs; Food/Cosmetics | 3 | Jun 1, 2026 · NAI | — |
| Thomas L. Ortel, MD FEI 3010697248 | Biologics; Drugs | 2 | Jul 17, 2023 · NAI | — |
| Tryton Medical FEI 3007210870 | Devices | 2 | Oct 30, 2018 · NAI | — |
| United Therapeutics Corporation FEI 3003825766 | Drugs | 6 | Feb 28, 2025 · VAI | 1 |
| UPS Supply Chain Solutions, Inc FEI 3014367401 | Drugs | 1 | Jun 29, 2023 · NAI | — |
| Valeant Pharmaceuticals, Na, Llc FEI 3011853383 | Drugs | 1 | May 28, 2010 · VAI | — |
| Vern Juel, M.D. FEI 3014666545 | Drugs | 1 | Oct 18, 2018 · NAI | — |
| Veterans Administration Medical Center Laboratory Service FEI 1074395 | Biologics | 7 | Mar 20, 2024 · NAI | — |
| ViiV Healthcare Company FEI 3016117087 | Drugs | 1 | Feb 7, 2020 · NAI | — |
| Vintage Bee, Inc. FEI 3010938736 | Food/Cosmetics | 1 | Jun 17, 2015 · NAI | — |
| Vlahovic, Gordana, M.d FEI 3008569846 | Devices | 1 | Feb 4, 2011 · VAI | 1 |
| West Logistics, LLC FEI 3013435803 | Food/Cosmetics | 2 | Nov 21, 2023 · NAI | — |
| Yuh-Chin T. Huang, MD FEI 3043546441 | Drugs | 1 | Jun 10, 2026 · VAI | 1 |
| Yukon Medical, LLC FEI 3009631669 | Devices | 2 | Apr 6, 2018 · VAI | 3 |
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.