Samsung Biologics Co., Ltd.
Form 483 issued May 27, 2025 · Yeonsu Incheon, South Korea
- Observations
- 4
- Pages
- 6
- FEI number
- 3010479596
In short: On May 27, 2025, FDA issued a Form 483 with 4 observations to Samsung Biologics Co., Ltd. in Yeonsu Incheon, South Korea (FEI 3010479596). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures implemented to prevent cross-contamination of drug substances during product change over (PCO)…
- 02
T he responsibilities and procedures applicable to the quality control…
- 03
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release…
- 04
Failure to follow established procedures for reporting and implementing changes…
This inspection in context
Questions about this 483
What did FDA find at Samsung Biologics Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Samsung Biologics Co., Ltd. inspected by FDA?
This Form 483 is dated May 27, 2025.
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.