United States Food and Drug Administration (USFDA) has concluded inspection at Cadila Healthcare’s manufacturing facilities located at St. Louis, MO, USA of Nesher Pharmaceuticals (USA) LLC (100% subsidiary of Zydus Pharmaceuticals USA). The inspection was carried out from May 13 to May 31, 2019. The inspection concluded with 3 observations at one facility and 8 observations at the other facility of Nesher Pharmaceuticals with a recommendation for Voluntary Action Indicated (VAI).
This was a product specific pre-approval inspection with general cGMP and there were no Data Integrity (DI) related observations. The company is confident of addressing these observations and responding to the USFDA at the earliest.
Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.
