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An FDA inspection of Southwest Technologies’ Kansas City, Missouri-based facility in February and March logged 13 observations, most relating to quality system failures and failure to track nonconforming products and submit Medical Device Reports. Read More
A February inspection of Bishop, Calif.-based NeuroField found the firm failed to report device failures for its neurofeedback devices, and it didn’t properly control products according to specifications, the FDA said. Read More
Bristol, Rhode Island-based devicemaker Huestis Machine Corp. was cited for numerous GMP failures in an 11-item Form 483 following a September 2017 inspection. Read More
The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies. Read More
The agency observed that 4 of 12 complaints reviewed involved a device manufactured by the company getting stuck to the customer’s teeth and in some cases required professional dental care. Read More