# FDA WARNING_LETTER - Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. - October 20, 2017

Source: https://www.keypedia.com/records/warning_letter/lijiang-yinghua-biochemical-and-pharmaceutical-co-ltd/6af133c1-b419-4253-985c-1349deb59d4c

> FDA WARNING_LETTER for Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. on October 20, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.
- Inspection Date: 2017-10-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 19, 2018, the FDA issued a Warning Letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. following an inspection from October 16-20, 2017, which identified significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). This renders their API adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include:
1. **Insufficient controls over computerized systems:** Laboratory equipment (HPLC, GC) lacked restricted access, with a single administrator username allowing all users to delete or modify files without an audit trail. This was a repeat deviation from a 2015 inspection.
2. **Failure to maintain complete data:** The firm could not provide electronic data from HPLC assay testing for API release, stability, and intermediate testing from September 2011 to May 2017, claiming accidental deletion.
3. **Failure to investigate deviations:** An HPLC injection for an intermediate stability sample showed an abnormal result, which was disregarded without documentation or investigation, and a subsequent "in-specification" injection was used for release.
4. **Quality unit failure to review and approve documents:** A Certificate of Analysis (COA) for an API batch was approved by the quality unit before all required testing was complete.

The FDA recommends retaining a qualified consultant for data integrity remediation. The firm must

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Compliance Officer, CDER, Office of Manufacturing](https://www.keypedia.com/people/joseph-r-lambert/d2968fda-8e5e-433a-b60b-f68aaef3b7b0)

Company: https://www.keypedia.com/companies/lijiang-yinghua-biochemical-and-pharmaceutical-co-ltd/47ca4d69-d8d4-4f42-b93a-e2cdb161a872

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c