Samsung Biologics Co., Ltd.
Form 483 issued September 1, 2023 · Incheon, South Korea
- Inspection
- Aug 21 – Sep 1, 2023
- Investigator
- Dae Totus
- Observations
- 6
- Pages
- 7
- FEI number
- 3010479596
In short: On September 1, 2023, FDA issued a Form 483 with 6 observations to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Aug 21 – Sep 1, 2023. The investigator was Dae Totus. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Manufacturing Scientific Analytical Technology (MSAT) laboratory used in support of application submission testing data had…
- 02
Writien production and process control procedures are not followed…
This inspection in context
Dae Totus
1 document · 2023
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Dae Totus is named on this Form 483, for the inspection of Aug 21 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Aug 21 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
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.