Samsung Bioepis Co. Ltd.
Form 483 issued November 22, 2024 · Incheon, South Korea
- Inspection
- Nov 20 – Nov 22, 2024
- Investigator
- Rajiv R. Srivastava
- Observations
- 2
- Pages
- 4
- FEI number
- 3010031951
In short: On November 22, 2024, FDA issued a Form 483 with 2 observations to Samsung Bioepis Co. Ltd. in Incheon, South Korea (FEI 3010031951) after an inspection that ran Nov 20 – Nov 22, 2024. The investigator was Rajiv R. Srivastava. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to dtu g products are…
- 02
Responsibilities and procedures for quality units are not in writing and/or followed to ensure a need…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSamsung Bioepis Co. Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Bioepis Co. Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Samsung Bioepis Co. Ltd.?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Nov 20 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Samsung Bioepis Co. Ltd. inspected by FDA?
The inspection ran Nov 20 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Samsung Bioepis Co. Ltd.?
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