Home » Lack of Understanding About Device Regulation Lands Company Form 483
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
The GMP Letter
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