Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Jan 2020
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.182
Written records kept in individual logs
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.186(a)
Master production and control records, procedure
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.194(a)
Complete test data included in records
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.194(b)
Test method modification records not maintained
Cited by Ucheabuchi C Chudi-Nwankwor
Inspected site
C&Church & Dwight Canada CorpMont-Royal, Canada
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere