FDA Inspection
Simple Diagnostics, Inc.Simple Diagnostics, Inc. – FDA Inspection, Jan 8, 2020
Record Details
This FDA Inspection record concerns Simple Diagnostics, Inc., with an inspection on January 8, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Simple Diagnostics, Inc.
- Inspection Date
- January 8, 2020
- Product Type
- Devices
View Company Profile
ID · ce37fa7e-c0b1-42bf-b80f-47049c901fc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115022
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Simple Diagnostics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Simple Diagnostics, Inc.
- FDA Inspection 1171014 - 2022-05-10
- FDA Inspection 1128795 - 2020-08-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.