FDA Inspection
General Hospital Supply Corp.General Hospital Supply Corp. – FDA Inspection, Apr 3, 2024
Record Details
This FDA Inspection record concerns General Hospital Supply Corp., with an inspection on April 3, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebdb28d2-0e30-405c-ae76-cd714dabf75d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234856
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.120(e)Control number {see also 820.65, 820.184(f)}
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(e)Records of complaint investigation - UDI
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Other FDA inspections of General Hospital Supply Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for General Hospital Supply Corp.
- FDA Inspection 990059 - 2016-09-22
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