Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
7 Jul 2010
21 CFR 111.27(a)(5)(i)
Refrigerator, freezer - temperature recording device
Cited by Iram R Hassan, Stephanie Durso
7 Jul 2010
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Iram R Hassan, Stephanie Durso
7 Jul 2010
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Iram R Hassan, Stephanie Durso
7 Jul 2010
21 CFR 111.110(c)
Quality control operations - tests, examinations; results
Cited by Iram R Hassan, Stephanie Durso
7 Jul 2010
21 CFR 111.210(a)
Master manufacturing record - dietary ingredients
Cited by Iram R Hassan, Stephanie Durso
Inspected site
KPKabco Pharmaceuticals, Inc.Amityville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(5)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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