Lack of Understanding About Device Regulation Lands Company Form 483

A California company that repackages and relabels imported therapeutic lamps ran afoul of the FDA, landing a 16-count Form 483 that suggests an overwhelming lack of corrective and prevention actions (CAPA), good manufacturing practices and other quality procedures. San Jose-based Prime Herbs attributed the compliance lapses cited during an Aug. 7-14 inspection by the FDA’s Alameda, Calif., district office to its belief that the company was not in the business of making devices. But the FDA disagreed.
The GMP Letter