We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Serious deficiencies in sterile drug production at Greenpark Compounding in Houston, Texas, may put patients at risk, the FDA said in a warning letter to the compounder. Read More
The FDA sent a warning letter listing a slew of violations to StemGenex Biologic Laboratories, following a January 16-26 inspection of its San Diego, California, facility. Read More
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Read More
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