FDA Inspection 1217039 — McPherson Enterprises, Inc., dba Implantable Devices
The FDA completed an inspection of McPherson Enterprises, Inc., dba Implantable Devices on September 6, 2023 in Pinellas Park, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 6, 2023
- Fiscal Year
- 2023
- 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 |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |