Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
12 Apr 2013
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Meredith P Soehl, Sarah A Meehan, Ann M Stewart
12 Apr 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Meredith P Soehl, Sarah A Meehan, Ann M Stewart
12 Apr 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Meredith P Soehl, Sarah A Meehan, Ann M Stewart
12 Apr 2013
21 CFR 111.75(h)(2)
Tests, examinations - scientifically valid
Cited by Meredith P Soehl, Sarah A Meehan, Ann M Stewart
12 Apr 2013
21 CFR 111.90(b)(1)
Reprocessed, dietary supplement - no material review
Cited by Meredith P Soehl, Sarah A Meehan, Ann M Stewart
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 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | 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 |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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