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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.
Nassif Associates received a recent FDA warning letter for current good manufacturing practice violations regarding the company’s cardio-card interpretation systems.
When designing medical devices that use radio-frequency (RF) wireless technology, firms should consider how those products will interact with other devices and respond to potential electromagnetic interference (EMI), the FDA says in new draft guidance.
The U.S. Food and Drug Administration (FDA) published a final rule in the Dec. 19 Federal Register on test procedures and accepted criteria for patient examination and surgeons’ gloves.
Skytron violated cGMPs and lacked adequate standards for complaint reviews, making its surgical beds adulterated and misbranded, an FDA warning letter said.
Dupaco violated cGMPs by not performing required tests or following complaint procedures on its blood/fluid warming sets, according to an FDA warning letter.
Rhein 83 must stop marketing its dental products in the U.S. because it lacks an approved premarket approval (PMA) application, an FDA warning letter said.