ABSTRACT

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshal

chapter 2|34 pages

Recalls: Corrections and Withdrawals

chapter 3|58 pages

Civil Actions

chapter 5|54 pages

Case Studies

chapter VIII|7 pages

Imports and Exports

chapter IX|6 pages

Miscellaneous