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Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements. Read More
The FDA issued warning letters to four drugmakers over various CGMP violations at their facilities, some of which created risks of product contamination. Read More
The FDA slapped Watertown, Massachusetts, drug manufacturer pSivida with a Form 483 after inspectors found that the facility lacked defined procedures to ensure drug uniformity and homogeneity. Read More
The FDA hit Pompano Beach, Florida, compounder Vital Rx with a warning letter for manufacturing deficiencies that resulted in adulterated drug products and potential risks for patients. Read More
The FDA issued a warning letter to United Exchange, a Cerritos, California-based drug manufacturer for filing inaccurate ingredient information for the National Drug Code (NDC) directory. Read More
Contract drugmaker Izeen Pharma of Frederick, Maryland, drew a 21-page Form 483 from the FDA for numerous deficiencies, including inadequate validations and poor data handling. Read More
Agency inspectors also observed serious CGMP violations during a June 13-29, 2017, inspection and noted that the facility failed to qualify for exemptions from FDA oversight under section 503B of the Food, Drug and Cosmetic Act. Read More