FDA Inspection 583439 — Synthes (USA) Products LLC
The FDA completed an inspection of Synthes (USA) Products LLC on April 27, 2009 in West Chester, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |