Samsung Biologics Co., Ltd.
Form 483 issued July 25, 2017 · Yeonsu-gu, South Korea
- Inspection
- Jul 21 – Jul 25, 2017
- Investigators
- Maria J. Lopez-Barragan· Patrick Lynch· Sarah Arden
- Observations
- 4
- Pages
- 2
- FEI number
- 3010479596
In short: On July 25, 2017, FDA issued a Form 483 with 4 observations to Samsung Biologics Co., Ltd. in Yeonsu-gu, lncheon (FEI 3010479596) after an inspection that ran Jul 21 – Jul 25, 2017. The investigators were Maria J. Lopez-Barragan, Patrick Lynch, Sarah Arden and Zhong Li. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls used to release'!bH-4> tirug substance do not incJude scientifically sound and appropriate test procedures…
- 02
Deviation investigations are…
- 03
Procedures to ensure microbial contro l oft.~_ . H__ _ _drug…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Maria J. Lopez-Barragan
2 documents · 2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Maria J. Lopez-Barragan, Patrick Lynch, Sarah Arden and Zhong Li are named on this Form 483, for the inspection of Jul 21 – Jul 25, 2017. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Jul 21 – Jul 25, 2017, and the Form 483 is dated July 25, 2017.
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.