The Infamous Form FDA 483: How you respond can make or break you
May 9, 2013
Location
san Francisco
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
USA
Description
Description:
The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
The issuance of a 483 by the CSO at the conclusion of an inspection will be discussed with the establishment's management and put them on notice that the nonconformities warrant correction and that a failure to do so may result in further action by the FDA, such as civil money penalties, seizure, injunction, and/or prosecution. Firm's are well advised to take the warning seriously.
Additional Information
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
Organized by
online compliance panel
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
United States of America
More Information
Contact: martin luthur
Email: onlinecompliancepanel1@gmail.com
Phone: +1-510-857-5896
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