Company
United StatesSDI Diagnostics, Inc., South Easton, MA – FDA Inspections
Inspection records and compliance data for SDI Diagnostics, Inc. in South Easton, Massachusetts. 3 FDA inspections on record, last inspected September 30, 2021.
Company Profile
This profile covers SDI Diagnostics, Inc. based in South Easton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 29, 2011. Last inspected September 30, 2021.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Justification for not reporting1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 30, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1153251 |
| September 10, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 847750 |
| April 29, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 726575 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SDI Diagnostics, Inc.
FEI Number
1220253
Address
10 Hampden Dr, South Easton, Massachusetts 02375, United States
Country
United States
ID: 7a3d0831-9376-4545-a7b1-d3655d2fe217