Company
United StatesAllwin Medical Devices Inc., Anaheim, CA – FDA Inspections
Inspection records and compliance data for Allwin Medical Devices Inc. in Anaheim, California. 3 FDA inspections on record, last inspected September 23, 2020.
Company Profile
This profile covers Allwin Medical Devices Inc. based in Anaheim, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 31, 2009. Last inspected September 23, 2020.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
- Documentation1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1132147 |
| May 10, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831430 |
| August 31, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 615987 |
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
Allwin Medical Devices Inc.
FEI Number
3005987240
Address
3305 E Miraloma Ave Ste 176, Anaheim, California 92806, United States
Country
United States
ID: 853db705-a742-4cf8-afeb-843a6f9b3179