Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
4 Jun 2019
21 CFR 117.206(a)
Modified Requirement Temp Control - Monitor, Corrective Action, Verification
Cited by Liliya V Bubiy, Nancy J Lucas
4 Jun 2019
21 CFR 117.80(c)(8)
Process Control - Foreign Objects
Cited by Liliya V Bubiy, Nancy J Lucas
Inspected site
COChicago Oriental Wholesale Market, IncChicago, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.206(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.93 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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