Samsung Biologics Co., Ltd.
Form 483 issued July 30, 2024 · Incheon, South Korea
- Inspection
- Jan 22 – Jul 30, 2024
- Investigators
- C. Ward· P. A. O'brien
- Observations
- 8
- Pages
- 10
- FEI number
- 3010479596
In short: On July 30, 2024, FDA issued a Form 483 with 8 observations to Samsung Biologics Co., Ltd. in Incheon, Maryland (FEI 3010479596) after an inspection that ran Jan 22 – Jul 30, 2024. The investigators were C. Ward and P. A. O'brien. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
PamMo[[oy pue “UsyLIM ‘payst|qeiso…
- 02
The firm did not meet the acceptable criteria for airflow and non-viable particulate monitoring for the…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Investigations of endotoxin failures…
This inspection in context
C. Ward
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in South Korea.
The firmSamsung Biologics Co., Ltd. history
All 14 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
C. Ward and P. A. O'brien are named on this Form 483, for the inspection of Jan 22 – Jul 30, 2024. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Jan 22 – Jul 30, 2024, and the Form 483 is dated July 30, 2024.
How do I get the full Form 483 for Samsung Biologics Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.