Company
United StatesSterling Diagnostics, Inc., Sterling Heights, MI – FDA Inspections
Inspection records and compliance data for Sterling Diagnostics, Inc. in Sterling Heights, Michigan. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected December 20, 2017.
Company Profile
This profile covers Sterling Diagnostics, Inc. based in Sterling Heights, Michigan, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 13, 2010. Last inspected December 20, 2017.
Most cited issue areas
- Design validation - simulated testing1 inspection
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 20, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1035513 |
| July 28, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 980678 |
| December 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 859085 |
| August 13, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 676805 |
FDA documents
Form 483s (1)
- Form 483s · July 28, 2016
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sterling Diagnostics, Inc.
FEI Number
1831796
Address
36645 Metro Ct, Sterling Heights, Michigan 48312, United States
Country
United States
ID: 8158744a-a7a5-478f-bb5e-0df2d2cc0a56