FDA Inspection
Allwin Medical Devices Inc.Allwin Medical Devices Inc. – FDA Inspection, May 10, 2013
Record Details
This FDA Inspection record concerns Allwin Medical Devices Inc., with an inspection on May 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Allwin Medical Devices Inc.
- Inspection Date
- May 10, 2013
- Product Type
- Devices
View Company Profile
ID · e91eb516-7968-4e22-86b3-4a4f3ffbea9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831430
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 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 Allwin Medical Devices Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Allwin Medical Devices Inc.
- FDA Inspection 1132147 - 2020-09-23
- FDA Inspection 615987 - 2009-08-31
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.