FDA Inspection
Douglas Medical Products, Inc.Douglas Medical Products, Inc. – FDA Inspection, Jun 24, 2026
Record Details
This FDA Inspection record concerns Douglas Medical Products, Inc., with an inspection on June 24, 2026, issued by the Chicago District Office, covering medical devices & rad health.
- Inspection Date
- June 24, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 32b735d3-cbeb-4c5b-99dd-b046624c8d9a
Inspection Facts
- Inspection number
- 1323366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Douglas Medical Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Douglas Medical Products, Inc.
- FDA Inspection 1160698 - 2021-12-14
- FDA Inspection 1026575 - 2017-09-21
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.