Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Jun 2009
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Hala L Selby, Vlada Matusovsky, Linda M Hoover, George Pyramides
4 Jun 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Hala L Selby, Vlada Matusovsky, Linda M Hoover, George Pyramides
4 Jun 2009
21 CFR 211.160(b)(1)
Sampling and testing procedures described
Cited by Hala L Selby, Vlada Matusovsky, Linda M Hoover, George Pyramides
4 Jun 2009
21 CFR 211.166(a)
Written program not followed
Cited by Hala L Selby, Vlada Matusovsky, Linda M Hoover, George Pyramides
4 Jun 2009
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Hala L Selby, Vlada Matusovsky, Linda M Hoover, George Pyramides
Inspected site
KBKenvue Brands LLCFort Washington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
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 6 observations
The source PDF and every observation in full, 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