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

Source: https://www.keypedia.com/records/483/ilshinchemical-coltd/cf550d25-69f7-4b5c-84c4-47111d2c2754

> FDA 483 for ILSHINCHEMICAL CO.,LTD. on April 27, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ILSHINCHEMICAL CO.,LTD.
- Inspection Date: 2012-04-27
- Product Type: drugs
- Office Name: Office of Compliance Intervention and Consultation
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/janete-a-eaker/19bd4a05-68ef-48fc-b659-1d4a3d3bac7e)

Company: https://www.keypedia.com/companies/ilshinchemical-coltd/436b1463-ec8f-47ad-bd1b-14ab18aaf6b0

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54