![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Lack of Understanding About Device Regulation Lands Company Form 483
Lack of Understanding About Device Regulation Lands Company Form 483
February 7, 2013
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 preventive action (CAPA), good manufacturing practice and other quality procedures.
The GMP Letter
The GMP Letter
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