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The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating sleep apnea without securing proper marketing authorization and for inadequate complaint handling. The agency also warned a device maker for misclassifying its products as premarket notification exempt pharmacy compounding kits.

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a producer of active pharmaceutical ingredients (APIs) based in India, citing the firms for violations of current good manufacturing practice (cGMP). Additionally, the agency warned a clinical investigator for informed consent, participant screening, and other issues related to the conduct of a clinical trial.

The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial protocols. The agency also cited several drug manufacturers for failing to adhere to current good manufacturing practices (CGMP).