Company
United StatesImmuno Concepts, N.A., Ltd, Dallas, TX – FDA Inspections
Inspection records and compliance data for Immuno Concepts, N.A., Ltd in Dallas, Texas. 1 FDA inspection on record, 1 Form 483, last inspected April 09, 2019.
Company Profile
This profile covers Immuno Concepts, N.A., Ltd based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 9, 2019.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Lack of System for Event Evaluations1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 9, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1085802 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Immuno Concepts, N.A., Ltd
FEI Number
3002810614
Address
2280 Springlake Rd Ste 106, Dallas, Texas 75234, United States
Country
United States
ID: be707744-029b-437b-9155-44a0cbabd06e