FEI 1000159368
General Hospital Supply Corp.
1050 Van Buren Ave, Indian Trail, NC, US
MDR events1All time
Recalls0All time
Registered products6
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
6 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000159368.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 3, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 3, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(b)(3)Apr 3, 2024
Management representative
- 21 CFR 820.20(d)Apr 3, 2024
Quality plan
- 21 CFR 820.22Apr 3, 2024
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(a)Apr 3, 2024
Design control - no procedures
- 21 CFR 820.100(a)Apr 3, 2024
Lack of or inadequate procedures
- 21 CFR 820.120Apr 3, 2024
Lack of or inadequate procedures for labeling
- 21 CFR 820.120(e)Apr 3, 2024
Control number {see also 820.65, 820.184(f)}
- 21 CFR 820.198(e)Apr 3, 2024
Records of complaint investigation - UDI
- 21 CFR 820.250(a)Apr 3, 2024
Statistical techniques - 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.