Samsung Biologics Co., Ltd.
Form 483 issued September 10, 2019 · Incheon, South Korea
- Inspection
- Sep 2 – Sep 10, 2019
- Investigators
- Maria Teresa Gutierroz-Lugo· Phillip Angart· Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 3010479596
In short: On September 10, 2019, FDA issued a Form 483 with 3 observations to Samsung Biologics Co., Ltd. in Incheon, Republic of (FEI 3010479596) after an inspection that ran Sep 2 – Sep 10, 2019. The investigators were Maria Teresa Gutierroz-Lugo, Phillip Angart and Wayne Seifert. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls 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
Utilities and Equipment are…
- 02
Written procedures to ensure control over the transfer of…
- 03
There is inadequate review…
This inspection in context
Maria Teresa Gutierroz-Lugo
2 documents · 2017–2019
Cites 211.100 (written procedures; deviations) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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.?
Maria Teresa Gutierroz-Lugo, Phillip Angart and Wayne Seifert are named on this Form 483, for the inspection of Sep 2 – Sep 10, 2019. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Sep 2 – Sep 10, 2019, and the Form 483 is dated September 10, 2019.
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.