FDA WARNING_LETTER - Yunnan Hande Bio-Tech. Co. Ltd. - April 17, 2014

On April 6, 2015, the FDA issued a Warning Letter to Yunnan Hande Bio-Tech. Co. Ltd. following an inspection from April 14-17, 2014, which identified significant deviations from CGMP regulations for active pharmaceutical ingredients (APIs). These deviations render their APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to prevent unauthorized data access/changes:** The IR spectrometer lacked access controls and audit trail functions, allowing deletion or alteration of raw data. The firm's proposed software upgrade and data archival plans were deemed insufficient as they didn't address immediate data integrity. 2. **Failure of quality unit to ensure proper testing and reporting:** An analyst altered an IR identity test file name to falsely support the release of two previously manufactured API lots, demonstrating a lack of accurate and truthful documentation. The firm's investigation into this data alteration was inadequate, not comprehensive, and did not review other computerized systems. 3. **Failure of quality unit to ensure CGMP compliance and meet specifications:** The quality unit failed to detect the altered IR raw data and misrepresented results. The firm's revised data review procedure and commitment to training were insufficient to address the quality unit's failure to prevent data manipulation.

The FDA stated these are serious CGMP deviations indicating an inadequate quality system