FDA Inspection 1288748 — PADCO HOLDING COMPANY, LLC
The FDA completed an inspection of PADCO HOLDING COMPANY, LLC on October 24, 2025 in Newbury, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newbury, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - 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 |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |