Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
20 Jan 2021
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Jennifer W Cheng-Dobson, James E Trabert
20 Jan 2021
21 CFR 117.4
Training of employees and records
Cited by Jennifer W Cheng-Dobson, James E Trabert
20 Jan 2021
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by Jennifer W Cheng-Dobson, James E Trabert
Inspected site
HYHan Yang CorpLakewood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(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) | Cited across public-safe Form 483 observations | 1x |
| n/a | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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