FDA Inspection 1271082 — Morgan Newton Comp.
The FDA completed an inspection of Morgan Newton Comp. on May 29, 2025 in Plano, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 29, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |