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The FDA uncovered serious complaint handling and CAPA deficiencies during an inspection of Alpha Source’s Milwaukee, Wisconsin facility from Jan. 17 to Feb. 2 and handed the firm an eight-item Form 483 at the close of the inspection. Read More
An FDA inspection of Southwest Technologies’ Kansas City, Missouri-based facility in February and March uncovered 13 observations, most relating to quality system failures and failure to track nonconforming products and submit Medical Device Reports. 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
All of the complaints were evaluated as not being reportable, but there was no information in the complaint records to support how the determination was made. Read More
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