Overview
- 12 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 8 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Harborage areas
Cited by Paul M Kawamoto, Julia E Chervoni, Kimberly J Proctor Jones, Marijo B Kambere, Jeffrey N Gerdes, Daniel A Congdon, Ngoc-Lan T Nguyen, Jonathan R Ormond
Contamination with microorganisms, chemicals, filth, etc.
Cited by Paul M Kawamoto, Julia E Chervoni, Kimberly J Proctor Jones, Marijo B Kambere, Jeffrey N Gerdes, Daniel A Congdon, Ngoc-Lan T Nguyen, Jonathan R Ormond
Floors, walls and ceilings
Cited by Paul M Kawamoto, Julia E Chervoni, Kimberly J Proctor Jones, Marijo B Kambere, Jeffrey N Gerdes, Daniel A Congdon, Ngoc-Lan T Nguyen, Jonathan R Ormond
Spacing of equipment
Cited by Paul M Kawamoto, Julia E Chervoni, Kimberly J Proctor Jones, Marijo B Kambere, Jeffrey N Gerdes, Daniel A Congdon, Ngoc-Lan T Nguyen, Jonathan R Ormond
Screening
Cited by Paul M Kawamoto, Julia E Chervoni, Kimberly J Proctor Jones, Marijo B Kambere, Jeffrey N Gerdes, Daniel A Congdon, Ngoc-Lan T Nguyen, Jonathan R Ormond
Inspected site
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 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(9) | 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 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