FDA Inspection 709138 — Church & Dwight Inc
The FDA completed an inspection of Church & Dwight Inc on February 17, 2011 in Princeton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |