FDA Inspection 1234856 — General Hospital Supply Corp.
The FDA completed an inspection of General Hospital Supply Corp. on Apr 3, 2024 in Indian Trail, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 3, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Indian Trail, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3314 | 21 CFR 820.120(e) | Control number {see also 820.65, 820.184(f)} |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |