FDA Inspection 732622 — Synthes, Inc.
The FDA completed an inspection of Synthes, Inc. on September 15, 2011 in West Chester, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 15, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Chester, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |
| 783 | 21 CFR 803.52(f)(6) | Evaluation Codes |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |