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
Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility. Recalls: Corrections and Withdrawals. Civil Actions. Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity. Case Studies. Appendix 1.FD&C Act of 1938. Appendix 2.Drug Law History Synopsis. Appendix 3.Clinical Investigators. Appendix 4.FDA Administrative Procedures Act (FAPA). Glossary. Index.