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The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
Japanese drugmaker Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues. Read More
As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers. Read More
The Morton Drug Company has received a warning letter as a result of FDA investigators witnessing unsanitary conditions at its Neenah, Wisconsin plant. Read More
The FDA hit the Dongying Tiandong Pharmaceutical Co. with a warning letter for failing to investigate and document out-of-specification results when testing drug batches as well as GMP violations. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited, received a warning letter that inspection of its facility revealed significant GMP violations. Read More