Company
United StatesBiosensics LLC, Newton, MA – FDA Inspections
Inspection records and compliance data for Biosensics LLC in Newton, Massachusetts. 3 FDA inspections on record, 3 Form 483s, last inspected February 09, 2026.
Company Profile
This profile covers Biosensics LLC based in Newton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected March 16, 2018. Last inspected February 9, 2026.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Corrective action not taken1 inspection
- Design and development procedures not documented1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1301914 |
| April 7, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1202256 |
| March 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1044469 |
FDA documents
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biosensics LLC
FEI Number
3010331770
Address
57 Chapel St Ste 200, Newton, Massachusetts 02458, United States
Country
United States
ID: 6e562ea7-1ac8-4d2a-966e-5eb9766dfe21