fda-inspection-records

FDA inspections of firms in Rochester, MN

93 firms in Rochester were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 54 NAI, 38 VAI, 1 OAI. Main product types: Drugs (31), Food/Cosmetics (28), Devices (25).

FirmProduct typesInspectionsLatest inspection483 observations posted
Abu Dayyeh, Barham, K., MD, MPH, Clinical Investigator
FEI 3014898784
Devices1Mar 5, 2019 · VAI—
Afsaneh Alavi, M.D.
FEI 3027266041
Drugs1Oct 18, 2023 · NAI—
Ambient Clinical Analytics
FEI 3010692333
Devices1Oct 31, 2023 · NAI—
Amit (nmi)Mahipal MD
FEI 3014935952
Biologics; Drugs2Mar 22, 2022 · NAI—
Animesh Pardanani
FEI 3015152714
Drugs1Mar 8, 2019 · VAI3
Anthony J. Windebank, M.D., Clinical Investigator
FEI 3015627649
Biologics1Sep 19, 2019 · VAI1
Apria Health Care Inc
FEI 2129798
Drugs1Aug 17, 2012 · NAI—
Associated Milk Producers, Inc.
FEI 2123788
Food/Cosmetics4Apr 19, 2017 · NAI5
Benchmark Electronics, Inc.
FEI 3000204692
Devices4Jun 4, 2026 · NAI—
Benjamin D. Elder, MD, PhD
FEI 3042755766
Devices1Mar 27, 2026 · VAI2
Bimbo Bakeries USA Inc.
FEI 3004329544
Food/Cosmetics1Apr 25, 2013 · NAI—
Blue Horizon Farm, LLP
FEI 3007045701
Veterinary1Oct 17, 2018 · VAI2
Boorjian, Stephan A, MD
FEI 3015519274
Drugs1Sep 26, 2019 · NAI—
City of Rochester dba Rochester International Airport
FEI 3006728106
Food/Cosmetics1Aug 26, 2025 · NAI—
Compass International Innovations Inc.
FEI 2183671
Devices4Jul 10, 2025 · NAI—
Daly, Dr. Richard C., MD, Clinical Investigator
FEI 3007279341
Devices1Jan 12, 2009 · VAI2
David Dingli
FEI 3014669390
Drugs1Oct 12, 2018 · NAI—
Delta Global Services
FEI 3011699898
Food/Cosmetics2Sep 5, 2018 · NAI—
Dooley's Inc.
FEI 3007663414
Devices1Jun 15, 2009 · NAI—
Dusica Babovic-Vuksanovic, M.D.
FEI 3038166801
Drugs1Jul 18, 2025 · NAI—
Elaine Wirrell, M.D.
FEI 3015222007
Drugs1Dec 19, 2019 · NAI—
Elite Custom Solutions
FEI 3004743815
Devices2Jul 9, 2025 · NAI—
Frank A. Sinicrope, M.D., Clinical Investigator
FEI 3017639903
Drugs1Feb 26, 2021 · VAI3
GILLETTE PEPSI COMPANIES INC
FEI 3000266328
Food/Cosmetics1May 7, 2013 · NAI—
Goldberg, Richard M., M.D., Clinical Investigator
FEI 3007605874
Drugs1Jun 5, 2009 · NAI—
Henry J. Schiller
FEI 3011380462
Drugs1Apr 14, 2015 · NAI—
Home Bakery dba The Gingerbread House Bakery
FEI 2180143
Food/Cosmetics3Nov 2, 2016 · VAI2
Howling Helga's
FEI 3008212155
Food/Cosmetics1May 19, 2011 · VAI—
Hy Vee, Inc
FEI 2180157
Food/Cosmetics3Mar 28, 2014 · NAI3
James L. Kirkland MD, PhD, Clinical Investigator
FEI 3017172902
Drugs1Jul 23, 2021 · VAI—
Jensen, Dr. Mikael, MD, Clinical Investigator
FEI 3011144553
Devices1Nov 14, 2014 · NAI—
John C. Lieske, M.D., Clinical Investigator
FEI 3025304850
Drugs1Mar 3, 2023 · NAI2
Joseph C. Hung, Ph.D. [Mayo Clinic]
FEI 3009583769
Drugs1Jun 28, 2012 · NAI—
Karthik V. Giridhar, MD
FEI 3043421414
Devices1Jun 18, 2026 · NAI—
Kemps LLC
FEI 2127579
Food/Cosmetics7Apr 21, 2023 · NAI—
Kemps, LLC
FEI 2129663
Food/Cosmetics3Nov 3, 2017 · NAI—
Kerry
FEI 2124476
Food/Cosmetics4Apr 2, 2025 · NAI4
KERRY INC
FEI 3004694509
Food/Cosmetics4Oct 22, 2019 · NAI—
Khosla, Sundeep, MD
FEI 3014866650
Devices1Dec 7, 2018 · VAI1
Klee, Dr. George
FEI 1000520247
Devices1Jan 28, 2010 · VAI—
LME , Div of Lakeville Motor Express, Inc
FEI 3004927346
Food/Cosmetics1Jun 14, 2016 · NAI—
Mara Piltin, D.O.
FEI 3027966785
Devices1May 3, 2024 · VAI2
Mayo Clinic Hospital - Rochester
FEI 3001452414
Biologics7Jan 27, 2026 · NAI2
Mayo Clinic Hospital - Rochester Methodist Campus Division of Transfusion Medicine
FEI 3003298248
Biologics7Nov 16, 2023 · NAI—
Mayo Clinic Hospital Rochester
FEI 3027556847
Biologics1Nov 22, 2024 · NAI—
Mayo Clinic IRB
FEI 2182468
Biologics; Devices; Drugs4Aug 27, 2021 · NAI2
Mayo Clinic PET Radiochemistry Facility
FEI 3009119769
Drugs5Sep 24, 2025 · VAI3
Mayo Clinic Rdrc IRB
FEI 2128440
Drugs1Jul 19, 2011 · VAI—
Mayo Clinic Rochester
FEI 3003406951
Biologics7Nov 2, 2023 · NAI4
Mayo Clinic Rochester, Division of Transfusion Medicine
FEI 2172560
Biologics8Sep 17, 2025 · NAI2
Mayo Clinic Rochester, Mayo Clinic Blood Donor Center - IBM
FEI 3001452303
Biologics4Jun 23, 2015 · NAI2
Mead Johnson & Co. LLC
FEI 3004650551
Food/Cosmetics1Nov 4, 2014 · NAI—
Medical Innovations International Inc.
FEI 2183762
Devices1Jun 28, 2022 · NAI—
Michael D. Leise, M.D., Clinical Investigator
FEI 3017458186
Devices1Aug 27, 2021 · VAI2
Midwest Eye Laboratories Inc
FEI 1000116180
Devices2Dec 13, 2023 · VAI3
MIDWEST ITALIAN IMPORTS LLC
FEI 3019959416
Food/Cosmetics2Mar 21, 2024 · NAI1
Morie A. Gertz, M.D., Clinical Investigator
FEI 3014108453
Drugs1Mar 9, 2018 · VAI—
Nassr, Ahmad, MD
FEI 3015533957
Devices1Feb 7, 2020 · VAI4
Nathan Smischney
FEI 3013429849
Drugs1Jul 5, 2017 · VAI2
NaviNetics, Inc.
FEI 3023194190
Devices1Mar 13, 2024 · NAI—
Nelson, Timothy, J., MD, PhD, Sponsor
FEI 3014863061
Biologics1Mar 21, 2019 · NAI—
Olmsted Medical Group IRB
FEI 3000718527
Drugs1Mar 11, 2014 · VAI—
Pan-O-Gold Baking Co.
FEI 3006425152
Food/Cosmetics1May 9, 2013 · NAI—
Patrick S. Kamath, M.D., Clinical Investigator
FEI 3030383372
Devices1Apr 26, 2024 · VAI2
Pharmaceutical Specialties, Inc.
FEI 2150117
Drugs; Food/Cosmetics4Aug 15, 2025 · VAI9
PIEPHO MOVING AND STORAGE INC
FEI 3004691352
Food/Cosmetics2Oct 3, 2019 · NAI—
Prairie Farms Dairy, Inc.
FEI 2127592
Food/Cosmetics4Jan 17, 2025 · NAI2
PSI Health Care, Inc.
FEI 3009928687
Drugs1Nov 3, 2014 · NAI—
Reichel Foods Inc
FEI 3002706418
Food/Cosmetics9Mar 1, 2024 · NAI19
Reichel Foods Inc.
FEI 2000024264
Food/Cosmetics1Feb 24, 2026 · NAI—
Resoundant Inc.
FEI 3013695852
Devices2Apr 15, 2026 · NAI—
Robert J. Pignolo, M.D., Ph.D.
FEI 3043544096
Drugs1May 7, 2026 · NAI—
Robert McBane, M.D.
FEI 3018120347
Drugs1Jun 23, 2021 · VAI1
Rolling Frito Lay Sales LP
FEI 2000047443
Food/Cosmetics1Mar 28, 2014 · NAI—
Sahil (nmi) Khanna, MBBS, MS, Clinical Investigator
FEI 3022160354
Biologics1Jun 10, 2022 · NAI—
Scott Okuno, M.D.
FEI 3016096078
Drugs1Feb 28, 2020 · VAI1
Seneca Foods Corporation
FEI 2128800
Food/Cosmetics3Aug 20, 2014 · NAI—
Seneca Foods, Corp.
FEI 3000204159
Food/Cosmetics1Dec 15, 2022 · NAI—
Signature Flight Support RST
FEI 3010504557
Food/Cosmetics1Sep 22, 2022 · NAI—
Specks, Dr. Ulrich, MD, Clinical Investigator
FEI 3008722311
Drugs1Mar 4, 2011 · NAI—
The Kroger Company
FEI 2123696
Food/Cosmetics; Veterinary6Jan 28, 2020 · NAI—
Thibodeau, Stephen N., MD, PhD, Clinical Investigator
FEI 3010366704
Devices1Aug 28, 2013 · NAI—
Veldhuis, Johannes, M.D., Clinical Investigator
FEI 3007744163
Drugs1Oct 9, 2009 · VAI1
Verghese (NMI) Mathew, M.D.
FEI 3011486802
Devices1Apr 24, 2015 · NAI—
Waters Medical Systems, LLC
FEI 2123774
Devices4Aug 14, 2024 · NAI3
William A. Faubion, Jr., M.D.
FEI 3010569502
Biologics; Drugs2May 7, 2026 · NAI—
Witzig , Dr. Thomas E., Clinical Investigator
FEI 3003243341
Drugs1Mar 4, 2013 · NAI—
Ya Ya-B, LLC
FEI 3008219105
Food/Cosmetics2May 14, 2015 · NAI—
Yao, Joseph Du-Che, MD, Clinical Investigator
FEI 3008433594
Biologics; Devices4Jan 8, 2020 · NAI—
Ye Olde Butcher Shoppe of Rochester, Inc.
FEI 3004398909
Food/Cosmetics3Feb 13, 2018 · NAI—
Yi Lin, M.D, PHD
FEI 3019511188
Biologics1Aug 6, 2021 · NAI—
Yuri A. Saito Loftus, MD, MPH, Sponsor-Investigator
FEI 3011931817
Drugs1Feb 8, 2016 · VAI6
Zelalem (nmi) Temesgen, M.D.
FEI 3023890995
Drugs1Nov 4, 2022 · 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.