ILSHINCHEMICAL CO.,LTD.April 27, 2012

FDA 483 - ILSHINCHEMICAL CO.,LTD. - April 27, 2012

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Record Details

ILSHINCHEMICAL CO.,LTD. in Yangsan, Korea, a manufacturer of dietary ingredients and APIs, was inspected by the FDA. The inspection revealed two observations related to inadequate storage conditions and facility maintenance in their finished product warehouse. Specifically, issues included temperature and humidity deviations, and structural deficiencies like gaps in an entry door, which could compromise product integrity.

Company: ILSHINCHEMICAL CO.,LTD.
Inspection Date: April 27, 2012
Product Type: Drugs
Office: Office of Compliance Intervention and Consultation
Person: Janete A. Eaker (investigator)

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