Overview
- 10 public-safe observations are available for this inspection.
- 9 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.
29 May 2018
21 CFR 112.140(b)
Records - equipment cleaning and sanitizing
Cited by Osama A Khatib, Patricia A Homola
29 May 2018
21 CFR 112.144(b)(1)
Testing spent irrigation water
Cited by Osama A Khatib, Patricia A Homola
29 May 2018
21 CFR 112.145(e)
Corrective action components of an environmental monitoring
Cited by Osama A Khatib, Patricia A Homola
29 May 2018
21 CFR 112.147(a)
Written sampling plan for spent irrigation water or sprouts
Cited by Osama A Khatib, Patricia A Homola
Inspected site
C&Chang & Son Enterprises, Inc.Whately, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 112.145(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 112.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.144(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.145(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.145(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.147(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.147(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 112.42(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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