Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Jul 2023
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Christina L Bigham
Inspected site
SESM ENG. Co. Ltd.Sasang, Korea (the Republic of)
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 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