Company
Korea (the Republic of)Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory), Hwaseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) in Hwaseong. 3 FDA inspections on record, 2 Form 483s, last inspected October 15, 2024.
Company Profile
This profile covers Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) based in Hwaseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected November 17, 2017. Last inspected October 15, 2024.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Written Procedures Not Followed1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 15, 2024 | Not classified | Human Drugs | 1288932 |
| August 24, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1179508 |
| November 17, 2017 | Not classified | Human Drugs | 1031684 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)
FEI Number
3012333115
Address
Hyangnam-Eub, 35-14 Jeyakgongdan4-Gil; Hyangnam-Eup, Hwaseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 2f9e6a6a-9f69-4377-b1ef-5500338ce477