# FDA 483 - Yicheng Chemical Corp. - July 21, 2017

Source: https://www.keypedia.com/records/483/yicheng-chemical-corp/f6f17950-eb68-46b3-b90f-77a3e70d6940

> FDA 483 for Yicheng Chemical Corp. on July 21, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yicheng Chemical Corp.
- Inspection Date: 2017-07-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Yicheng Chemical Corp. in Changzhou, China, was inspected by the FDA from July 17-21, 2017, and received eight observations. The inspection revealed significant deficiencies across its Active Pharmaceutical Ingredient (API) manufacturing operations, including a complete lack of a quality control unit, inadequate testing and release procedures, and no written procedures for critical processes like recall, calibration, production controls, or stability testing. These findings indicate a severe lack of fundamental quality systems and controls for API handling and distribution.

## Related Documents

- [WARNING_LETTER - 2017-07-21](https://www.keypedia.com/records/warning_letter/yicheng-chemical-corp/86ccd684-81c7-41df-8fa7-cc48897458d0)

## Related Officers

- [Charanjeet Jassal](https://www.keypedia.com/people/charanjeet-jassal/85aad819-fe9c-41dd-8280-23bcbeb8826c)

Company: https://www.keypedia.com/companies/yicheng-chemical-corp/7f20aaae-19d2-4626-9d41-a722f2ce3bb3

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