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The FDA flagged South Korean drug manufacturer EEJE for quality and testing deficiencies observed during a July 30 to Aug. 2 inspection of its facility in Gyeongsangnam-do province. Read More
One of the firm’s gauges measuring differential pressure between its ISO 8 anteroom and an unclassified area had a reading of zero, the agency said. Read More
The firm’s ISO 7 cleanroom also contained items that were complicated to clean, such as a computer keyboard, a hand-held calculator and many pieces of particle-generating paper. Read More
The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March 20-23 inspection. Read More
The FDA hit Genus Lifesciences with a Form 483 following a July inspection of its Allentown, Pa., drug facility, citing inadequate reviews of discrepancies and failure to reject substandard products. Read More
The FDA knocked compounding pharmacy People’s Custom Rx and Clinical Care with a Form 483, taking the firm to task over unsanitary practices and a failure to conduct endotoxin testing on finished products. Read More
The FDA hit Murrieta, Calif., compounder Innovative Intrathecal Solutions with a warning letter over serious violations that caused its drug products to be adulterated. Read More
The agency also flagged the company’s storage conditions, observing that a warehouse used to store finished drug products had no temperature and humidity controls. Read More