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Splintek, a division of Power Products, must stop marketing its Sleep Right adjustable night guard for OTC purchase because the company did not gain premarket approval to sell the device without a prescription, an FDA warning letter said.
The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
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 Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.
The FDA warned Lee Laboratories for several current good manufacturing practice (cGMP) violations, most of which were repeat violations from a previous agency inspection.
The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures. One of the firm's devices also lacked premarket approval, the agency said.
The FDA sent the Craftmatic Organization a warning letter for failing to handle and report product complaints, but the company said it should not have received the letter because it did not manufacture the devices.
The FDA warned Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.
The FDA warned Daiichi Sankyo for promotional items it said were misleading because they obscured risk information for Evoxac, a drug that treats dry mouth in patients with Sjogren’s syndrome.