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

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