FDA issued a Warning Letter to Amaros Co., Ltd on 12/13/2017 as a result of this inspection.
FDA investigators audited the Amaros - Seongnam, Korea (the Republic of) facility and issued inspectional observations (via FDA 483) on 12 May 2017.
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- Category: Human Drugs
- Inspection end: 12 May 2017
- Location: Seongnam, Korea (the Republic of)
- FEI: 3010518986