Company
Korea (the Republic of)Amaros Co., Ltd, Seongnam, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Amaros Co., Ltd in Seongnam. 1 FDA inspection on record (1 OAI), 1 Form 483, 1 warning letter, last inspected May 12, 2017.
Company Profile
This profile covers Amaros Co., Ltd based in Seongnam, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
Inspected May 12, 2017.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Active ingredient retained sample kept1 inspection
- Contract drug products--lack of responsibility1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 12, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1014013 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amaros Co., Ltd
FEI Number
3010518986
Address
Jungwon, 14 Sagimakgol-Ro 45beon-Gil, Seongnam, Korea (the Republic of)
Country
Korea (the Republic of)
ID: a6cfcacf-ff74-4ed2-a661-a9f7350ceb92