FDA Inspection 1001126 — McPherson Enterprises, Inc., dba Implantable Devices
The FDA completed an inspection of McPherson Enterprises, Inc., dba Implantable Devices on February 9, 2017 in Pinellas Park, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 9, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pinellas Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |