FDA Inspection 1028729 — Synthes (USA) Products LLC
The FDA completed an inspection of Synthes (USA) Products LLC on October 13, 2017 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 13, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |