FDA Inspection
Church & Dwight Canada Corp.Church & Dwight Canada Corp. – FDA Inspection, Jan 17, 2020
Record Details
This FDA Inspection record concerns Church & Dwight Canada Corp., with an inspection on January 17, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Church & Dwight Canada Corp.
- Inspection Date
- January 17, 2020
- Product Type
- Drugs
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ID · 5335145c-84dd-4a40-b227-cc7be3e20c20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115291
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.194(b)Test method modification records not maintained
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Church & Dwight Canada Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| July 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Church & Dwight Canada Corp.
- FDA Inspection 1260925 - 2025-02-07
- FDA Inspection 1236384 - 2024-07-18
- FDA Inspection 1034441 - 2017-12-08
- FDA Inspection 968739 - 2016-02-26
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