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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
The FDA hit N-Molecular, doing business as SOFIE, with a warning letter after an inspection of the company’s positron emission tomography (PET) drug manufacturing facility in Haverhill, Mass., brought to light numerous hygiene violations. Read More