GLOSSARYUS
Adulterated
Section 501(h) of the Federal Food, Drug, and Cosmetic Act makes a device adulterated when its manufacture, packing, storage, or installation does not conform to the quality system requirements. Introducing an adulterated device into interstate commerce is a prohibited act.
Avoid This Mistake
Adulterated does not require a contaminated or defective device. Under 21 CFR 820.10(e), failing to comply with any applicable Part 820 requirement is enough.