Overview
- 16 public-safe observations are available for this inspection.
- 15 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.
26 Sep 2011
21 CFR 110.10(b)(7)
Storage of personal items
Cited by Hugh Grimoldby, David A Quale, Willis L Hicks, Jason T Lovelady
26 Sep 2011
21 CFR 110.10(b)(9)
Precautions against contamination--micro, foreign substances
Cited by Hugh Grimoldby, David A Quale, Willis L Hicks, Jason T Lovelady
26 Sep 2011
21 CFR 110.10(c)
Level of competency (S)
Cited by Hugh Grimoldby, David A Quale, Willis L Hicks, Jason T Lovelady
26 Sep 2011
21 CFR 110.20(a)(1)
Harborage areas
Cited by Hugh Grimoldby, David A Quale, Willis L Hicks, Jason T Lovelady
26 Sep 2011
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Hugh Grimoldby, David A Quale, Willis L Hicks, Jason T Lovelady
Inspected site
KIKJ3 IncTacoma, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 16 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