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.
Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company’s Guayama, Puerto Rico, manufacturing facility, the firm announced.
Abbott Laboratories is retaining an outside consultant to audit its manufacturing and quality assurance systems at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told GMP.
Boston Scientific anticipates that it will be ready for the FDA to audit its drug-eluting stent manufacturing operations and compliance systems by mid-2007, according to Chief Operating Officer Paul LaViolette.
Companies should create strong policies to monitor and regulate compliance with the Foreign Corrupt Practices Act (FCPA), as the number of cases in the healthcare industry is growing, an industry expert said.
Medicare payments for inhalation drugs will be assessed differently to ensure pharmacies are making compounded products strictly for medical needs and not to turn a large profit, according to the official in charge of Medicare.
The SEC will soon issue guidance laying out a more flexible approach to meeting Sarbanes-Oxley (SOX) reporting and auditing requirements, easing the burdens on smaller companies.
The SEC will soon issue guidance laying out a more flexible approach to meeting Sarbanes-Oxley (SOX) reporting and auditing requirements, easing the burdens on smaller companies.
A key goal of GMP training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems, who spoke at an FDAnews audioconference last month. Read More