FDA’s Chicago District Office warns Corpak MedSystems about Quality System and Medical Device Reporting regulation violations in its manufacturing of disposable medical devices.
In its latest batch of Warning Letters, FDA cites Alveologic, Birkdale Medicinals, Corpak MedSystems, Excel Medical Products, KayPentax, Oy Ajat, Puget Sound Blood Center, Synticare, and Women’s Health Institute of Texas.
Attorneys Lynn Tyler and Hae Park Suk say companies should be aware of the potential for impostors to present themselves for a fraudulent FDA inspection.
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on reporting harmful constituents in tobacco products.
Federal Register Request: The Reagan-Udall Foundation for the FDA requests nominations for its Innovation in Medical Evidence Development and Surveillance Steering Committee.
FDA’s MedWatch program announces a Class 1 recall for LifeScan Inc.’s One Touch Verio IQ Blood Glucose Meter because it will fail to provide a warning at extremely high blood-glucose levels.
FDA and CytRx reach an agreement on a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas.