FDA 483 - Hubei Honch Pharmaceutical Co, Ltd. - March 20, 2025

An FDA inspection was conducted from March 17 to March 20, 2025, at "hen Pct indy," a manufacturing facility located in Huanggang, Hubei Province, China. The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations concerning the company's quality control and data management practices.

The first observation identified deficiencies in the verification of testing methods. Specifically, the company's laboratory records lacked proper documentation for the suitability of its testing methods, with a system suitability record notably absent for a batch manufactured on September 5, 2024. This indicates a gap in ensuring the reliability and validity of critical analytical test results.

The second observation highlighted inadequate controls over computer systems that manage control records. It was noted that audit trail capabilities, which are essential for tracking changes to data, were not enabled for the HPLC unit E-QC-124 during the analysis of a specific lot number on September 9, 2024. This raises concerns about data integrity and the ability to verify that only authorized personnel institute changes to control records.

These findings suggest areas where the company's quality system needs enhancement to ensure adherence to manufacturing standards. "hen Pct indy" is expected to provide a comprehensive response outlining its planned or implemented corrective actions to resolve these observations and prevent their recurrence.