Samsung Biologics Co., Ltd.
Form 483 issued February 28, 2023 · Incheon, South Korea
- Inspection
- Feb 20 – Feb 28, 2023
- Investigators
- Laurel A. Beer· Prabhu P. Raju
- Observations
- 3
- Pages
- 4
- FEI number
- 3010479596
In short: On February 28, 2023, FDA issued a Form 483 with 3 observations to Samsung Biologics Co., Ltd. in Incheon, Jncheon (FEI 3010479596) after an inspection that ran Feb 20 – Feb 28, 2023. The investigators were Laurel A. Beer and Prabhu P. Raju. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit were not always fully followed. The…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
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 3 observations on this Form 483, mostly about quality system, laboratory controls 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.?
Laurel A. Beer and Prabhu P. Raju are named on this Form 483, for the inspection of Feb 20 – Feb 28, 2023. Each investigator has a profile showing what they cite most.
When was Samsung Biologics Co., Ltd. inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2023, and the Form 483 is dated February 28, 2023.
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.