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The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls. Read More
The investigator also noted inconsistent and unreliable manufacturing processes that likely resulted in batches of inconsistent quality, purity and strength. 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 hit Australian drugmaker Delta Laboratories with a warning letter for significant violations, including unreliable manufacturing processes, flawed stability testing and a lack of stability data. Read More
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