Company
United StatesMEDDEV USA, INC., Dallas, TX – FDA Inspections
Inspection records and compliance data for MEDDEV USA, INC. in Dallas, Texas. 1 FDA inspection on record (1 OAI), last inspected May 11, 2012.
Company Profile
This profile covers MEDDEV USA, INC. based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected May 11, 2012.
Most cited issue areas
- Design control - no procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 11, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 780737 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MEDDEV USA, INC.
FEI Number
3009257101
Address
100 Highland Park Vlg FL 200, Dallas, Texas 75205, United States
Country
United States
ID: 03f1adb0-2eb7-40d6-ba2c-14b9c79ba385