Samsung Biologics Co., Ltd.
Form 483 issued June 22, 2016 · Incheon, South Korea
- Inspection
- Jun 13 – Jun 22, 2016
- Investigators
- Deborah Schmiel· Marion Michaelis· Monica Markovski
- Observations
- 13
- Pages
- 10
- FEI number
- 3010479596
In short: On June 22, 2016, FDA issued a Form 483 with 13 observations to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Jun 13 – Jun 22, 2016. The investigators were Deborah Schmiel, Marion Michaelis, Monica Markovski, Reyes Candau-Chacon and Sarah Kennett. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 8 of 12 observations.
Most cited: 21 CFR 211.113 (4×) · 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no assurance that HEPA filters inside the RABS filling line, room were integral during…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed…
- 03
Procedures for personnel environmental monitoring after aseptic…
- 04
There is no assurance that the OO oF used for | glass vials is maintained in…
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 13 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Deborah Schmiel, Marion Michaelis, Monica Markovski, Reyes Candau-Chacon and Sarah Kennett are named on this Form 483, for the inspection of Jun 13 – Jun 22, 2016. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Jun 13 – Jun 22, 2016, and the Form 483 is dated June 22, 2016.
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.