FDA Inspection 579548 — McPherson Enterprises, Inc., dba Implantable Devices
The FDA completed an inspection of McPherson Enterprises, Inc., dba Implantable Devices on May 5, 2009 in Pinellas Park, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pinellas Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |