Overview
- 13 public-safe observations are available for this inspection.
- 11 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.
3 Jun 2009
21 CFR 110.10(b)(1)
Suitable outer garments
Cited by Janete F Guardia, Rebecca B Welch, Michael J Pasternak
3 Jun 2009
21 CFR 110.20(b)(2)
Contamination with microorganisms, chemicals, filth, etc.
Cited by Janete F Guardia, Rebecca B Welch, Michael J Pasternak
3 Jun 2009
21 CFR 110.35(d)
Failure to clean - general
Cited by Janete F Guardia, Rebecca B Welch, Michael J Pasternak
3 Jun 2009
21 CFR 110.35(d)(3)
Non-food-contact surfaces (S)
Cited by Janete F Guardia, Rebecca B Welch, Michael J Pasternak
3 Jun 2009
21 CFR 110.37(a)
Safe and adequate sanitary quality
Cited by Janete F Guardia, Rebecca B Welch, Michael J Pasternak
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 110.80 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.10(b)(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 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(b) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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