Company
United StatesSigma Diagnostics Inc., Livonia, MI – FDA Inspections
Inspection records and compliance data for Sigma Diagnostics Inc. in Livonia, Michigan. 1 FDA inspection on record, 1 Form 483, last inspected January 11, 2018.
Company Profile
This profile covers Sigma Diagnostics Inc. based in Livonia, Michigan, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected January 11, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Equipment Installation, Placement, Specified Requirements1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1037793 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sigma Diagnostics Inc.
FEI Number
3011189186
Address
14155 Farmington Rd, Livonia, Michigan 48154, United States
Country
United States
ID: d3d1843f-aa4f-43f4-a5f6-da922d1d818f