Company
United StatesNeomedix Corporation, Tustin, CA – FDA Inspections
Inspection records and compliance data for Neomedix Corporation in Tustin, California. 4 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected June 19, 2019.
Company Profile
This profile covers Neomedix Corporation based in Tustin, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected December 29, 2011. Last inspected June 19, 2019.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - production units1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 19, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1098182 |
| March 29, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1047029 |
| September 19, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 896544 |
| December 29, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 761781 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Neomedix Corporation
FEI Number
3003698071
Address
15042 Parkway Loop Ste A, Tustin, California 92780, United States
Country
United States
ID: 4c7ebf26-90bd-4090-9d8d-12b641ea60a5