fda-inspection-records

FDA inspections of firms in Gainesville, FL

78 firms in Gainesville were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 46 NAI, 26 VAI, 6 OAI. Main product types: Devices (24), Biologics (21), Food/Cosmetics (18).

FirmProduct typesInspectionsLatest inspection483 observations posted
Adaptive Equipment, Inc.
FEI 3003116030
Devices1Oct 4, 2011 · NAI—
AFTERNOON ROASTING
FEI 3023009046
Food/Cosmetics1Jun 9, 2026 · NAI—
Alaris Biologic Technologies, Inc.
FEI 3010898668
Biologics3Mar 2, 2018 · VAI20
Allograft Innovations, LLC
FEI 3006018016
Biologics3Oct 3, 2012 · VAI22
Aranda Juan, MD
FEI 3007209619
Devices2Nov 16, 2011 · NAI—
Arthur C. Lee, MD
FEI 3014910692
Devices2Feb 16, 2023 · NAI—
Bageland, Incorporated
FEI 3005944521
Food/Cosmetics1Aug 31, 2011 · NAI—
Barry J. Byrne, M.D., Ph.D.
FEI 3005355446
Biologics1Dec 12, 2019 · NAI—
Ben E. Keith Company
FEI 1013938
Food/Cosmetics1Apr 1, 2026 · NAI—
Biago A. Pietra, M.D.
FEI 3019693861
Drugs1Aug 6, 2021 · NAI—
Biomonde US, LLC
FEI 3011126619
Devices1Nov 17, 2017 · VAI7
Bottling Group, LLC
FEI 3004320465
Food/Cosmetics1Mar 28, 2018 · NAI—
BPC Plasma, Inc.
FEI 1072432
Biologics8Jul 19, 2023 · NAI—
Bret Wiechmann, MD
FEI 3015419612
Devices1Jul 3, 2019 · NAI—
Canteen Gainesville
FEI 1000526460
Food/Cosmetics1May 13, 2026 · NAI—
Charles Klodell, MD
FEI 3012700904
Devices1Nov 3, 2016 · VAI1
Dr. Brian Harris
FEI 3011580307
Veterinary2Oct 31, 2018 · NAI—
Eduardo Garin
FEI 3007421154
Drugs1Mar 22, 2017 · NAI—
EEG Software LLC
FEI 3010129717
Devices3Aug 27, 2026 · VAI8
Exactech, Inc.
FEI 1038671
Biologics; Devices14Aug 27, 2025 · OAI29
Florida Probe Corporation
FEI 1039382
Devices2Feb 14, 2017 · VAI17
Fruit of the Boot, Inc.
FEI 3004309468
Food/Cosmetics1Sep 14, 2021 · NAI—
Gainesville Ice Company
FEI 3004063167
Food/Cosmetics1Jun 4, 2019 · NAI—
Giuseppe Morelli, MD
FEI 3010192261
Drugs1Jun 27, 2013 · NAI—
GONZALEZ FARM USA LLC
FEI 3020965368
Food/Cosmetics1Jul 12, 2024 · VAI1
HBT Donut Inc.
FEI 1080682
Food/Cosmetics3Apr 2, 2019 · VAI3
Hess Philip, MD
FEI 3009262574
Devices1Jan 26, 2012 · VAI1
I.M.A. Electronics, Inc.
FEI 3006371990
Devices3Dec 16, 2019 · NAI2
Imaging Engineering LLC
FEI 3015437189
Devices1Nov 2, 2023 · NAI—
Invivo Corporation
FEI 1000113495
Devices1Dec 16, 2011 · NAI2
Invivo Corporation
FEI 3005722672
Devices1Feb 17, 2012 · NAI—
Jorge Lascano, M.D.
FEI 3015000517
Drugs1Feb 26, 2019 · VAI—
Josef Neu, M.D.
FEI 3013190690
Biologics1Jul 14, 2017 · NAI—
KEDPLASMA LLC
FEI 1052135
Biologics4Mar 12, 2020 · NAI—
Kim and Kyle Straughn Honey, LLC
FEI 3004278501
Food/Cosmetics1Jan 27, 2026 · NAI—
LifeSouth Community Blood Centers, Inc
FEI 3003707120
Biologics; Devices11Sep 12, 2024 · NAI42
LifeSouth Community Blood Centers, Inc.
FEI 1076458
Biologics7Aug 18, 2025 · VAI7
Lions Eye Institute for Transplant & Research, Inc.
FEI 3011402906
Biologics3Sep 12, 2019 · NAI—
Medical Device Technologies, Inc.
FEI 1036710
Devices1Sep 23, 2011 · NAI—
Melissa E. Elder, MD
FEI 3041534415
Biologics1Mar 13, 2026 · NAI—
Michael J. Haller, MD
FEI 3005562428
Biologics1Jan 29, 2020 · NAI—
Myolyn Inc.
FEI 3013503259
Devices1Sep 14, 2018 · VAI6
Natural Dynamics Inc.
FEI 3021193814
Food/Cosmetics1Apr 14, 2025 · VAI—
Neobiosis LLC
FEI 3017371366
Biologics1Feb 21, 2023 · OAI6
Noble Anesthesia-Air, Inc.
FEI 3004904578
Devices2Apr 2, 2013 · NAI7
North Florida Reg. Hospital IRB
FEI 1048058
Drugs1Mar 26, 2015 · NAI—
North Florida Regional Medical Center
FEI 3005959602
Biologics5Feb 15, 2019 · NAI3
Northwest Seafood Inc.
FEI 3002957380
Food/Cosmetics1Apr 19, 2011 · NAI—
Okun, Michael S., MD
FEI 3010950123
Devices1Sep 23, 2014 · NAI—
Owens and Minor Distribution Inc.
FEI 3010057947
Food/Cosmetics1May 18, 2023 · NAI—
Peter Stacpoole, M.D.
FEI 3003656614
Drugs1Jun 15, 2017 · VAI7
Philip Toskes, M.D.
FEI 3003070860
Drugs1Mar 12, 2010 · VAI—
Philips DS North America LLC
FEI 3023385454
Devices1Jan 16, 2025 · NAI—
Philips Medical Systems (Cleveland) Inc
FEI 3018004899
Devices1Jan 16, 2025 · NAI—
Piedmont Airlines Inc.
FEI 3011361653
Food/Cosmetics1Jan 16, 2025 · NAI—
Pure Laboratories Manufacturing (Gainesville)
FEI 3011318489
Tobacco2Dec 19, 2024 · NAI—
Quick-Med Technologies, Inc
FEI 3008029811
Devices1May 3, 2013 · VAI9
Regenerative Biologics, Inc.
FEI 3003567004
Biologics6Nov 5, 2024 · NAI—
RGI Medical Manufacturing, Inc.
FEI 3004994611
Devices1Aug 15, 2011 · VAI7
Risco Carl.os, DVM
FEI 3007155090
Veterinary1Nov 13, 2008 · NAI—
Roberto T. Zori, M.D.
FEI 3032804604
Drugs1Nov 15, 2024 · NAI—
Royal Cup, Inc.
FEI 3004337849
Food/Cosmetics1Dec 8, 2014 · NAI—
Shands Hospital Stem Cell Laboratory
FEI 3003926742
Biologics1Aug 10, 2010 · NAI—
Shands Teaching Hospital and Clinics
FEI 3004960725
Biologics1Nov 19, 2025 · NAI—
SILLIKER INC
FEI 3017442763
Drugs1Apr 25, 2024 · OAI5
Southeast Signal Inc.
FEI 3013391394
Devices1Sep 11, 2018 · VAI6
Staud, Roland, M.D.
FEI 3007517812
Drugs1Jun 23, 2009 · VAI2
SYNDICATE GLOBAL DISTRIBUTION
FEI 3015230214
Tobacco1Dec 19, 2024 · NAI—
The H.T. Hackney Co.
FEI 3004215917
Food/Cosmetics1Nov 29, 2018 · NAI—
The Original Alans Cubana Inc
FEI 3002865531
Food/Cosmetics1Apr 25, 2011 · VAI4
Tung Thanh Wynn, MD
FEI 3011305031
Biologics1Mar 16, 2015 · NAI—
UF Health Shands Medical Laboratories Blood Bank
FEI 1073823
Biologics7Aug 18, 2025 · NAI1
UF Reproductive Medicine at Springhill
FEI 3003926999
Biologics7Feb 9, 2026 · NAI3
University Air Center
FEI 3006166706
Food/Cosmetics2Jul 1, 2019 · NAI—
University of Florida IRB
FEI 3005045058
Drugs2Feb 16, 2017 · NAI—
University of Florida Meat Processing Center
FEI 3030771607
Veterinary1Dec 6, 2024 · NAI—
Veterans Administration Medical Center
FEI 1000025903
Biologics7Aug 19, 2025 · NAI4
Westlab Pharmacy, Inc. dba Westlab Pharmacy
FEI 3007426960
Drugs2Oct 5, 2021 · VAI9

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.