Samsung Biologics Co., Ltd.
Form 483 issued June 9, 2022 · Incheon, South Korea
- Inspection
- Jun 2 – Jun 9, 2022
- Investigator
- Madushini Dharmasena
- Observations
- 3
- Pages
- 2
- FEI number
- 3010479596
In short: On June 9, 2022, FDA issued a Form 483 with 3 observations to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Jun 2 – Jun 9, 2022. The investigator was Madushini Dharmasena. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The endotoxin detection method is not reliable to detect endotoxin consistently in all the in-process and…
- 02
Written procedures for cleaning and maintenance provide inadequate description of actions to be…
- 03
Investigations conducted to resolve…
This inspection in context
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Madushini Dharmasena is named on this Form 483, for the inspection of Jun 2 – Jun 9, 2022. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Jun 2 – Jun 9, 2022, and the Form 483 is dated June 9, 2022.
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.