FDA Inspection 1115291 — Church & Dwight Canada Corp.
The FDA completed an inspection of Church & Dwight Canada Corp. on Jan 17, 2020 in Mont-Royal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 17, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mont-Royal (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |