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FDA investigators found that Apple Medical’s procedures regarding its gynecologic electrocautery devices violated several current good manufacturing practice regulations, the agency said in a warning letter.
HemoSense's medical devices are adulterated due to current good manufacturing practice violations regarding its complaint handling and investigating system, an FDA warning letter said.
The FDA learned through Hardy Diagnostics’ recent voluntary recall of its HardyCHROM O157 device that the company was marketing the device without approval, an agency warning letter said.
The FDA warned Stem Cell Pharma for implanting stem cells in test subjects without following any standard operating procedures (SOPs) and without an approved license.
The FDA warned automatic external defibrillator (AED) maker MRL for several current good manufacturing practice (cGMP) violations and said the company's devices are adulterated and misbranded.
GE OEC Medical Systems, its parent company, General Electric (GE) — doing business as GE Healthcare — and two of GE’s top executives have signed an FDA consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA said in a recent announcement.
The FDA warned WellSpring Pharmaceutical for a print advertisement the agency said was misleading and overstated the safety and effectiveness of its drug, including using inappropriate studies as supporting evidence.
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
Skytron violated current good manufacturing practices and lacked adequate standards for complaint reviews, making its surgical beds adulterated and misbranded, an FDA warning letter said.