FDA 483 - Chongqing Bioland Pharmaceutical Ltd. - January 13, 2025

Chongqing Bioland Pharmaceutical Ltd, a non-sterile API manufacturer in Chongqing, China, was cited for significant deficiencies across laboratory controls, facilities, and equipment. Observations included inadequate analytical method transfer and testing procedures, incomplete laboratory records due to discarded raw data, and insufficient monitoring and calibration of the (b) (4) water system. Additionally, the firm lacked scientific rationale for environmental monitoring in clean rooms and had facility design flaws that could lead to API contamination.