Overview
- 12 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Aug 2015
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Mindy M Chou, Michael R Dominick, Yvonne M Santiago
21 Aug 2015
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Mindy M Chou, Michael R Dominick, Yvonne M Santiago
21 Aug 2015
21 CFR 110.80
Reasonable precautions
Cited by Mindy M Chou, Michael R Dominick, Yvonne M Santiago
21 Aug 2015
21 CFR 110.80
Reasonable precautions
Cited by Mindy M Chou, Michael R Dominick, Yvonne M Santiago
21 Aug 2015
21 CFR 110.80(b)(2)
Manufacturing conditions
Cited by Mindy M Chou, Michael R Dominick, Yvonne M Santiago
Inspected site
K&K & P Marketplace LTDMount Kisco, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 observations
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