Company
United StatesGentuity, LLC, Sudbury, MA – FDA Inspections
Inspection records and compliance data for Gentuity, LLC in Sudbury, Massachusetts. 2 FDA inspections on record, 1 Form 483, last inspected March 05, 2026.
Company Profile
This profile covers Gentuity, LLC based in Sudbury, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 16, 2022. Last inspected March 5, 2026.
Most cited issue areas
- Complaint handling procedures not documented1 inspection
- Corrective action not taken1 inspection
- Purchased product verification activities are inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1307694 |
| September 16, 2022 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1180446 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gentuity, LLC
FEI Number
3011578544
Address
142 North Rd Ste G, Sudbury, Massachusetts 01776, United States
Country
United States
ID: bc756f97-e3e4-4eac-8be2-9773d64a3f42