Samsung Biologics Co., Ltd.
Form 483 issued May 11, 2018 · Incheon, South Korea
- Inspection
- May 7 – May 11, 2018
- Investigators
- Diane Raccasi· Michael R. Shanks· Virginia A. Carroll
- Observations
- 5
- Pages
- 4
- FEI number
- 3010479596
In short: On May 11, 2018, FDA issued a Form 483 with 5 observations to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran May 7 – May 11, 2018. The investigators were Diane Raccasi, Michael R. Shanks and Virginia A. Carroll. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to prevent microbial contamination of drug products purporting to be…
- 02
The Quality Control Unit lacks authority to review production records to assure that…
- 03
Deviations from written GMP procedures are…
- 04
Equipment used in production operations…
This inspection in context
Diane Raccasi
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Diane Raccasi, Michael R. Shanks and Virginia A. Carroll are named on this Form 483, for the inspection of May 7 – May 11, 2018. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran May 7 – May 11, 2018, and the Form 483 is dated May 11, 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.