Specialty Health Products, Llc.
2514 E Mohawk Ln Ste 111, Phoenix, AZ, US
Registered product codes
2 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 2027347.
FDA inspections
2 on file
- Official Action Indicated (OAI)Dec 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
15 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 820.22Quality audits - Lack of or inadequate procedures
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
1
- 21 CFR 801.20(a)Dec 11, 2025
Label to bear a unique device identifier
- 21 CFR 820.22Dec 11, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Dec 11, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Dec 11, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Dec 11, 2025
Procedures not adequately established or maintained
- 21 CFR 820.50Dec 11, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Dec 11, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Dec 11, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(b)Dec 11, 2025
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Dec 11, 2025
Lack of or inadequate procedures
- 21 CFR 820.120Dec 11, 2025
Lack of or inadequate procedures for labeling
- 21 CFR 820.181Dec 11, 2025
DMR - not or inadequately maintained
- 21 CFR 820.184Dec 11, 2025
DHR content
- 21 CFR 820.198(a)Dec 11, 2025
Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Dec 11, 2025
Servicing - Lack of or inadequate procedures
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.