In short: On August 24, 2021, FDA issued a Form 483 with 1 observation to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Aug 13 – Aug 24, 2021. The investigators were Chen Sun and Yun Wu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance criteria for cleaning validation are not always justified to…
This inspection in context
Chen Sun
3 documents · 2019–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Chen Sun and Yun Wu are named on this Form 483, for the inspection of Aug 13 – Aug 24, 2021. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Aug 13 – Aug 24, 2021, and the Form 483 is dated August 24, 2021.
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.