Company
Korea (the Republic of)Dongkook Pharmaceutical Co., Ltd., Seoul, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Dongkook Pharmaceutical Co., Ltd. in Seoul. 1 FDA inspection on record, 1 Form 483, last inspected November 30, 2018.
Company Profile
This profile covers Dongkook Pharmaceutical Co., Ltd. based in Seoul, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected November 30, 2018.
Most cited issue areas
- Approve or reject procedures or specs1 inspection
- Establish reliability of supplier's C of A1 inspection
- Lack of written stability program1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 30, 2018 | Not classified | Human Drugs · Drug Quality Assurance | 1074954 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dongkook Pharmaceutical Co., Ltd.
FEI Number
3004967587
Address
7 Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 78dd5d21-f936-4b43-931a-4957a3a6daba