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The FDA issued a warning letter to Chinese API maker Zhejiang Huahai, the company implicated in a global recall of contaminated valsartan, for failing to adequately investigate the root cause of the NDMA contamination at its Linhai, Taizhou Zhejiang facility. Read More
The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude heparin sodium to the EU. Read More
The FDA hit Swedish drug manufacturer Apotek Produktion & Laboratorier with a Form 483 for failure to reject inadequate drug products and to secure analytical equipment at its facility in Stockholm. Read More
The FDA cited FMK Labs for deficiencies in its standard operating procedures during an Oct. 16-22 inspection of its Corona, California facility. Read More
Sterile drug manufacturer Horizon Pharmaceuticals found itself in the agency’s crosshairs for violations at its Riviera Beach, Florida Facility, receiving a Form 483 for issues found at its facility. Read More
“Without this testing, you do not have scientific evidence that all drug product batches you manufactured meet their established specifications prior to release,” the agency said. Read More
The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19 inspection. Read More