Company
United StatesSimple Diagnostics, Inc., Maspeth, NY – FDA Inspections
Inspection records and compliance data for Simple Diagnostics, Inc. in Maspeth, New York. 3 FDA inspections on record, last inspected May 10, 2022.
Company Profile
This profile covers Simple Diagnostics, Inc. based in Maspeth, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 8, 2020. Last inspected May 10, 2022.
Most cited issue areas
- Design control - no procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 10, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1171014 |
| August 25, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1128795 |
| January 8, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1115022 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Simple Diagnostics, Inc.
FEI Number
3007384659
Address
5208 Grand Ave Ste 201, Maspeth, New York 11378, United States
Country
United States
ID: a1507838-f54e-494c-bd14-1f503e3cad28