fda-inspection-records

FDA inspections of firms in Burlington, MA

25 firms in Burlington were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 6 NAI, 17 VAI, 2 OAI. Main product types: Devices (20), Drugs (7), Biologics (5).

FirmProduct typesInspectionsLatest inspection483 observations posted
Avedro, a Glaukos Company
FEI 3007851054
Devices; Drugs3Feb 10, 2016 · VAI4
BK Medical Holding Company
FEI 3008194047
Devices1May 27, 2022 · VAI3
Brooke R. Seckel, M.D.
FEI 3008594862
Devices2Mar 25, 2014 · VAI5
Cambridge Interventional Llc
FEI 3015257340
Devices1Feb 14, 2024 · NAI—
Curia Massachusetts, Inc.
FEI 3002951540
Devices; Drugs9Jun 29, 2023 · NAI6
Edge Surgical Inc.
FEI 3014282569
Devices2Jul 30, 2025 · NAI—
EMD Millipore Corporation
FEI 2244894
Devices; Drugs2Jan 5, 2010 · NAI5
Flexion Therapeutics, Inc.
FEI 3010734762
Devices1Jun 13, 2017 · VAI—
Jonathan S. Silver MD
FEI 3010141808
Devices1Jun 5, 2013 · VAI1
Keystone Dental Inc
FEI 3005990499
Biologics; Devices3Jun 8, 2017 · VAI6
Lahey Clinic Hospital Inc
FEI 1270015
Biologics9Jun 5, 2024 · NAI4
Lahey Clinic, Inc. IRB
FEI 1283376
Biologics; Devices; Drugs3Oct 18, 2021 · NAI—
Lasik Vision Institute
FEI 3006004807
Devices1Aug 12, 2009 · NAI—
LeMaitre Vascular, Inc.
FEI 1220948
Biologics; Devices11May 16, 2023 · VAI14
Perceptive Informatics LLC
FEI 3009351636
Drugs18Jun 24, 2026 · NAI3
PharmaEssentia US
FEI 3016854654
Drugs1Jul 7, 2020 · NAI—
QSA Global Inc.
FEI 3002108047
Devices4May 21, 2024 · NAI1
Rebecca's Cafe Corporation
FEI 3011022229
Food/Cosmetics1May 10, 2019 · VAI2
Rhythmia Medical Inc
FEI 3008438351
Devices1Mar 25, 2015 · VAI2
scPharmaceuticals Inc.
FEI 3013722099
Devices; Drugs2Jan 25, 2024 · VAI1
Sekisui Diagnostics, LLC
FEI 3008776041
Devices2Dec 10, 2019 · NAI3
SpineFrontier, Inc.
FEI 3005977257
Biologics; Devices6Apr 2, 2026 · VAI10
Teratech Corporation
FEI 3002315840
Devices2Aug 28, 2013 · NAI6
Thoratec Corporation
FEI 1218444
Devices5May 17, 2018 · NAI7
Wellness Pet LLC
FEI 3014421558
Veterinary2Dec 13, 2023 · 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.