Samsung Biologics Co., Ltd.
Form 483 issued June 26, 2018 · Incheon, South Korea
- Inspection
- Jun 18 – Jun 26, 2018
- Investigators
- Deborah Schmiel· Lucila B. Nwatu
- Observations
- 3
- Pages
- 3
- FEI number
- 3010479596
In short: On June 26, 2018, 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 18 – Jun 26, 2018. The investigators were Deborah Schmiel and Lucila B. Nwatu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Deborah Schmiel
5 documents · 2016–2024
Cites 211.113 (control of microbiological contamination) 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 211.25
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 facilities & equipment and quality system. 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.?
Deborah Schmiel and Lucila B. Nwatu are named on this Form 483, for the inspection of Jun 18 – Jun 26, 2018. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Jun 18 – Jun 26, 2018, and the Form 483 is dated June 26, 2018.
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.