Samsung Biologics Co., Ltd.
Form 483 issued November 1, 2019 · Incheon, South Korea
- Inspection
- Oct 24 – Nov 1, 2019
- Investigator
- Matthew B. Casale
- Observations
- 1
- Pages
- 2
- FEI number
- 3010479596
In short: On November 1, 2019, FDA issued a Form 483 with 1 observation to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Oct 24 – Nov 1, 2019. The investigator was Matthew B. Casale. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control procedures are…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.100(b)
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Matthew B. Casale is named on this Form 483, for the inspection of Oct 24 – Nov 1, 2019. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Oct 24 – Nov 1, 2019, and the Form 483 is dated November 1, 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.