Simplifying Global Compliance
FDAnews Device Daily Bulletin
Lack of Understanding About Device Regulation Lands Company Form 483
Feb. 8, 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
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