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When future new study data standards are listed in the Catalog, the new standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice. Read More
Wong Lap Kwong Medicine Company drew a warning from the FDA for failing to identify active pharmaceutical ingredients and to establish procedures for numerous basic functions in its Hong Kong facility. Read More
The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility. Read More
The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination. Read More
The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created a public health concern. Read More