Daewoo Pharmaceutical Co., Ltd.

Form 483 issued January 15, 2025 · Busan, South Korea

Observations: 13
Pages: 18
FEI number: 1000448124

In short: On January 15, 2025, FDA issued a Form 483 with 13 observations to Daewoo Pharmaceutical Co., Ltd. in Busan, Busan (FEI 1000448124). Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

Observations span 4 systems, led by production.

Production4

Facilities & equipment3

Quality system3

Laboratory controls2

Other1

Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
02
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be…
03
21 CFR 211.42
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.42
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…

9 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Daewoo Pharmaceutical Co., Ltd. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Daewoo Pharmaceutical Co., Ltd.?

FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

When was Daewoo Pharmaceutical Co., Ltd. inspected by FDA?

This Form 483 is dated January 15, 2025.

How do I get the full Form 483 for Daewoo Pharmaceutical 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.