FDA EIR - Shenzhen Oriental Pharmaceutical Co Ltd - November 29, 2024

An FDA preannounced surveillance inspection of Shenzhen Oriental Pharmaceutical Co. Ltd. (Oriental), a manufacturer of human Active Pharmaceutical Ingredients (APIs) located in China, took place from November 25 to November 29, 2024. This inspection was conducted under the FY25 Foreign Drug Inspection work plan, adhering to Compliance Program 7356.002F and the Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients. The assessment reviewed key areas including quality, materials, facilities and equipment, production, and packaging and labeling systems. While a previous 2019 inspection resulted in formal observations (FDA-483), which were subsequently corrected, the current inspection concluded without issuing an FDA-483. However, two important discussion items were identified for the company's attention. Firstly, the firm needs to ensure that master batch production records accurately document the weighing of materials, identify the balance used, and confirm that executor and verifier signatures are recorded after the completion of actions, not before. Secondly, the company was advised to update its drug registration list to precisely reflect the current market status of its products. The inspection received a "No Action Indicated (NAI)" classification, signifying that no significant regulatory enforcement action is required. The implied actions for the company are to address the two discussion points to maintain robust compliance with manufacturing practice standards.