Daewoo Pharmaceutical Co., Ltd.
FDA inspection history in Busan, South Korea, 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One warning letter and one Form 483, at Busan, South Korea.
Cited most
Across all Daewoo Pharmaceutical Co. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete Daewoo Pharmaceutical Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Busan, South Korea
One Form 483 · 2025 · 13 observations
Latest: Form 483, Jan 15, 2025 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-02 | Warning letter Warning letter | — | — | $99 |
| 2025-01-15 | 483 Form 483 | Busan, South Korea | 13 | $99 |
FEI number 1000448124 · most recent document Jul 2, 2025
About Daewoo Pharmaceutical Co., Ltd.
How many FDA Form 483s has Daewoo Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Daewoo Pharmaceutical Co., Ltd.; the most recent is dated Jan 15, 2025.
When was Daewoo Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Daewoo Pharmaceutical Co., Ltd. is a Form 483 dated Jan 15, 2025, for the site in Busan, South Korea.
What did FDA cite at Daewoo Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Daewoo Pharmaceutical Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Daewoo Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Daewoo Pharmaceutical Co., Ltd.; the most recent is dated Jul 2, 2025.