Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China
YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).
- YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).
- The inspection, carried out by the FDA Consumer Safety Officer, Mrs. Michele Glendenning, lasted 5 days (7–11.Aug.2023) as initially planned.
- The FDA inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
- Dr. Li Jinliang, Board Director of Aurisco, said "We are pleased to have another successful FDA inspection.