# FDA 483 - Everlight Chemical Industrial Corporation Kuanyin II Plant - Unknown Date

Source: https://www.keypedia.com/records/483/everlight-chemical-industrial-corporation-kuanyin-ii-plant/c1f3956e-19a7-4874-a6b9-0fa17c47b17d

> FDA 483 for Everlight Chemical Industrial Corporation Kuanyin II Plant on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Everlight Chemical Industrial Corporation Kuanyin II Plant
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Everlight Chemical Industrial Corporation in Kuanyin Hsiang, Taiwan, from April 7-10, 2015, revealed significant data integrity and quality system deficiencies. The firm failed to properly investigate out-of-specification results, retain raw data, prevent unauthorized data changes, and document operations contemporaneously. Other serious issues included inadequate process validation, lack of endotoxin monitoring for injectable APIs, and insufficient quality unit oversight.

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/everlight-chemical-industrial-corporation-kuanyin-ii-plant/7b2b80af-fdf0-4f5a-b662-459bc22670ce

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd