In a warning letter posted online June 17, the Food and Drug Administration told Tianjin Zhongan Pharmaceutical Co. that it found significant deviations of current good manufacturing practices (cGMPs) at the active pharmaceutical ingredient (API) manufacturing facility in Tianjin, China.
The violations were found during an FDA inspection that ended Sept. 27, 2013, the agency letter said.
The agency said these deviations cause the company’s APIs to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act.
The FDA said it reviewed the company’s response but the response lacks sufficient corrective actions.
Specific Violations.
The FDA said ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.