Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Jul 2021
21 CFR 803.18(b)(1)(i)
Adverse events--all info not in file
Cited by Gamal A Norton, Benjamin E Bowen
15 Jul 2021
21 CFR 803.18(b)(1)(i)
Adverse events--all info not in file
Cited by Gamal A Norton, Benjamin E Bowen
15 Jul 2021
21 CFR 820.198(c)
Investigation of device failures
Cited by Gamal A Norton, Benjamin E Bowen
15 Jul 2021
21 CFR 820.198(c)
Investigation of device failures
Cited by Gamal A Norton, Benjamin E Bowen
15 Jul 2021
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Gamal A Norton, Benjamin E Bowen
Inspected site
CCColgate-Palmolive CompanyMorristown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.18(b)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF, 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