Adulteration

Products not made according to cGMPs render those products to be adulterated under the cGMPs and the Food, Drug, and Cosmetic Act.

CHAPTER V - DRUGS AND DEVICES

SUBCHAPTER A - DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICES

SEC. 501. [351] A drug or device shall be deemed to be adulterated -

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(2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

(B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;

 

Actions that can be taken by the FDA when the cGMPs aren't followed range from "voluntary actions" that can be taken by firms to "regulatory actions" taken by the FDA against the firm and those responsible for noncompliance.

The actions in the column to the left are listed in order of increasing significance and "pain" to the firm.