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FDA Administrative Enforcement Manual
DOI link for FDA Administrative Enforcement Manual
FDA Administrative Enforcement Manual book
FDA Administrative Enforcement Manual
DOI link for FDA Administrative Enforcement Manual
FDA Administrative Enforcement Manual book
ByFlorence R. Parker
Edition 1st Edition
First Published 2005
eBook Published 18 February 2005
Pub. Location Boca Raton
Imprint CRC Press
Pages 480
eBook ISBN 9780429125065
Subjects Bioscience, Engineering & Technology
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Parker, F.R. (2005). FDA Administrative Enforcement Manual (1st ed.). CRC Press. https://doi.org/10.1201/9781420037838
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
TABLE OF CONTENTS
chapter 1|40 pages
Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility
ByFlorence R. Parker
chapter 4|56 pages
Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity
ByFlorence R. Parker
chapter III|13 pages
Appendix 1. FD&C Act of 1938 ................................................................................................. 243
ByChapter III. Prohibited Acts and Penalties
chapter V|106 pages
Drugs and Devices....................................................................................................... 256
BySubchapter A. Drugs and Devices
