Immuno Diagnostic Center, Inc.
10042 MONROE DRIVE, DALLAS, TX, US
Registered product codes
1 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000118715.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 12, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 12, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.40(b)Change records, content
121 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
121 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
121 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
1
- 21 CFR 820.40(b)Feb 12, 2025
Change records, content
- 21 CFR 820.50(a)(3)Feb 12, 2025
Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(2)Feb 12, 2025
Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.72(a)Feb 12, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Feb 12, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 12, 2025
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.