Company
Korea (the Republic of)Samchundang Pharm Co., Ltd., Hwaseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Samchundang Pharm Co., Ltd. in Hwaseong. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected October 27, 2022.
Company Profile
This profile covers Samchundang Pharm Co., Ltd. based in Hwaseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected September 8, 2017. Last inspected October 27, 2022.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Scientifically sound laboratory controls2 inspections
- Aseptic Processing Area1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1182341 |
| October 25, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1107697 |
| September 8, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1024442 |
FDA documents
Form 483s (2)
- Form 483s · May 19, 2026
- Form 483s · October 25, 2019
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Samchundang Pharm Co., Ltd.
FEI Number
3008425092
Address
Hyangnam Pharmaceutical Industries Complex, 71 Jeyakgongdan2-Gil; Hyangnam-Eup, Hwaseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 953048a3-14c3-475b-bebc-f43b8755905e