Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
26 Jun 2018
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.63
Equipment Design, Size and Location
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.63
Equipment Design, Size and Location
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.67(b)
Written procedures fail to include
Cited by Lucila B Nwatu, Deborah H Schmiel
Inspected site
SBSamsung Biologics Co., Ltd.Yeonsu District, Korea (the Republic of)
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF and 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