Samsung Biologics Co., Ltd.
Form 483 issued March 14, 2018 · Incheon, South Korea
- Inspection
- Mar 8 – Mar 14, 2018
- Investigators
- Alicia Mozzachio· Riley Myers· Thuy T. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3010479596
In short: On March 14, 2018, FDA issued a Form 483 with 2 observations to Samsung Biologics Co., Ltd. in Incheon, South Korea (FEI 3010479596) after an inspection that ran Mar 8 – Mar 14, 2018. The investigators were Alicia Mozzachio, Riley Myers and Thuy T. Nguyen. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Pest control alert limit and action limit are inadequate in that your alert and action…
This inspection in context
Alicia Mozzachio
2 documents · 2017–2018
Cites 211.192 (production record review) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Samsung Biologics Co., Ltd.?
Alicia Mozzachio, Riley Myers and Thuy T. Nguyen are named on this Form 483, for the inspection of Mar 8 – Mar 14, 2018. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Mar 8 – Mar 14, 2018, and the Form 483 is dated March 14, 2018.
How do I get the full Form 483 for Samsung Biologics Co., Ltd.?
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