FDA Inspection
Church & Dwight IncChurch & Dwight Inc – FDA Inspection, Feb 17, 2011
Record Details
This FDA Inspection record concerns Church & Dwight Inc, with an inspection on February 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Church & Dwight Inc
- Inspection Date
- February 17, 2011
- Product Type
- Devices
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ID · cf112e37-a1c9-4190-a780-572ffed5e131
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709138
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Church & Dwight Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 6, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Church & Dwight Inc
- FDA Inspection 1135841 - 2020-08-14
- FDA Inspection 937165 - 2015-08-06
- FDA Inspection 762722 - 2012-02-13
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