ABSTRACT
It is recommended that the program implementation case study procedure provided in Section 3.2.9 of Chapter 3 be applied to the cases presented in this chapter, which are intended to assist with an understanding of the variations in how the Food and Drug Administration (FDA) has enforced technical terms of the regulations in the past and how this history can be applied to industry participants today with regard to Administrative Enforcement issues. The program implementation case study method will help determine the extent of the compliance program needed and whether or not the proposed implementation complies with the intent of the Food, Drug, and Cosmetics (FD&C) Act; amendments to the act; and Title 21 CFR 210-211 et seq. This case study review method is also useful when a concern exists with regard to implementation problems or compliance program gaps. When reading the various case studies included here, keep in mind that the FDA does not absolve industry participants from compliance in all areas, especially those documented in correspondence that serves as prior notice of violations.
