chapter 1 Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility -- chapter 2 Recalls: Corrections and Withdrawals -- chapter 3 Civil Actions -- chapter 4 Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity -- chapter 5 Case Studies -- chapter III Appendix 1. FD&C Act of 1938. 243 / chapter V Drugs and Devices. 256 / chapter VIII Imports and Exports -- chapter IX Miscellaneous.