FDA Inspection 1274181 — Pointcore Supply Chain Service LLC
The FDA completed an inspection of Pointcore Supply Chain Service LLC on Jun 26, 2025 in Peoria, IL. 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
- Jun 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Peoria, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |