FDA 483 - Chongqing Bioland Pharmaceutical Ltd - January 15, 2025

During an inspection conducted by the FDA from January 13-15, 2025, at the facility of Ne Hum Rd in Chongqing, China, several significant observations were noted regarding their non-sterile Active Pharmaceutical Ingredient (API) manufacturing operations. The inspection, resulting in an FDA Form 483, highlighted critical deficiencies across laboratory controls, facility management, and environmental monitoring, affecting APIs distributed to the US market. In the laboratory control system, the firm lacked scientifically sound and appropriate procedures. Specifically, issues included unapproved analytical method transfers, the absence of scientific rationale for applying "inhibit integrations" during analysis, and incomplete records, evidenced by discarded balance printouts of raw data. Regarding facilities and equipment, observations indicated inadequate controls for monitoring critical alarms within buildings and for the water distribution system. Furthermore, environmental monitoring measures were deemed insufficient; the firm failed to establish scientific rationale for active, passive, and contact sampling locations in cleanroom areas, potentially leading to cross-contamination. Structural deficiencies were also observed, with significant gaps in weighing and dispensing rooms, exposing starting materials and APIs to potential environmental contamination, especially since these areas lacked monitoring classifications. These observations indicate a failure to adhere to established quality standards for API manufacturing. The company is required to implement comprehensive corrective actions to address these deficiencies and ensure the quality and safety of products intended for US distribution.