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FDA Inspection
•Daewoo Pharmaceutical Co., Ltd.•January 15, 2025

Daewoo Pharmaceutical Co., Ltd. – FDA Inspection, Jan 15, 2025

Record Details

This FDA Inspection record concerns Daewoo Pharmaceutical Co., Ltd., with an inspection on January 15, 2025, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Daewoo Pharmaceutical Co., Ltd.
Inspection Date
January 15, 2025
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Rowena S. Nguyen (Issuing Officer)
  • Sandra A. Boyd (Investigator)
View Company Profile

ID · ceb4bcdf-d411-482c-a9aa-957dc615b70d

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1258203
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

Other FDA inspections of Daewoo Pharmaceutical Co., Ltd.

2
DateClassificationOfficeProject area
February 22, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 28, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Daewoo Pharmaceutical Co., Ltd.
  • FDA Inspection 1083809 - 2019-02-22
  • FDA Inspection 1009230 - 2017-03-28

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