FDA EIR - Shandong Xinhua Pharmaceutical Co., Ltd. - September 15, 2023

An FDA surveillance inspection of Shandong Xinhua Pharmaceutical Co., Ltd., a foreign manufacturer of veterinary and human active pharmaceutical ingredients, was conducted from September 11 to September 15, 2023. This inspection was part of the fiscal year 2023 surveillance plan and covered the company's quality, material, packaging and labeling, and laboratory systems. The regulatory framework for this inspection included cGMP guidance, specifically CP 7371.001 for Animal Drug Manufacturing Inspections, 73.56002F for Active Pharmaceutical Ingredients, and ICH Q7. Notably, the inspection concluded with no FDA Form 483 issued, indicating that no significant observations or violations requiring immediate corrective action were identified. The overall classification for this inspection was 'No Action Indicated' (NAI). While a previous review in 2021 had noted an issue regarding laboratory analysts not properly documenting each page during testing, the current inspection confirmed that this matter had been corrected. No samples were collected, and the firm did not refuse the inspection. The next follow-up will be routine surveillance as per standard procedures, with no specific required actions stemming from this visit.