FDA EIR - Zhaoke Pharmaceutical (Hefei) Company Limited - June 18, 2024

An FDA inspection of Zhaoke Pharmaceutical (Hefei) Company Limited, a manufacturer of sterile drug products, took place from June 11 to June 18, 2024. This was the firm's first inspection by the FDA and resulted in an Official Action Indicated (OAI) classification, signifying that regulatory action is warranted.

The inspection identified several critical deficiencies related to regulatory standards for pharmaceutical manufacturing. A 7-item Form FDA 483 was issued, detailing concerns such as incomplete laboratory records and inadequate laboratory controls necessary for ensuring component quality. Significant issues were observed regarding the prevention of microbiological contamination, including insufficient validation of aseptic and sterilization processes, and the absence of established, written procedures for preventing contamination. Other violations involved the lack of written procedures for equipment cleaning and maintenance, equipment design and location not suitable for operations, and inadequate assurance of data backup completeness. Crucially, the firm was not registered with the FDA at the time of this inspection. The company's management acknowledged the findings and committed to submitting a written response to the agency within 15 business days.