The official website of China Food and Drug Administration released a warning letter on December 1 to urge pharmaceutical product manufacturing enterprises to investigate risks and enhance pharmaceutical product quality.
As expressed by the news release of CFDA, China Food and Drug Administration sent warning letters to partial pharmaceutical product manufacturing enterprises a few days ago, requiring them to carefully investigate the relevant risk information prompted in the exploratory study of Chinese pharmaceutical product snap check, promptly make improvement, and continue to enhance pharmaceutical product quality. CFDA required the food and drug administration of each province (district and city) to specifically strengthen supervision and administration on enterprises, and urge and guide enterprises for investigation and rectification.
Since founding, CFDA has been adhering to conducting pharmaceutical product quality snap check based on problems, and strengthening the exploratory study of factors affecting pharmaceutical product quality, to continuously enhance the quality assurance level of pharmaceutical product quality. Based on the results of the exploratory study of pharmaceutical product snap check, the warning content this time proposed possible problems of partial pharmaceutical products in aspects such as quality control that are required to be further enhanced and improved. The purpose of sending warning letters to pharmaceutical product manufacturing enterprises was to require enterprises to investigate, analyze and verify the relevant problems, and take necessary measures for quality enhancement or improvement, which can be beneficial to driving enterprises to continuously enhance pharmaceutical product quality and implement pharmaceutical product safety responsibility.
