FDA Inspection 1205244 — Morgan Newton Comp.
The FDA completed an inspection of Morgan Newton Comp. on May 12, 2023 in Plano, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |