FDA Inspection 1261760 — WillowWood Global Llc
The FDA completed an inspection of WillowWood Global Llc on Feb 4, 2025 in Mount Sterling, OH. 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
- Feb 4, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mount Sterling, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |