Glossary
Marie A Fadden
FDA Investigator Details
Marie A Fadden
Visit Investigator ProfileInvestigation Details
Last Issued Date
March 21, 2013
Conversion Rate
0
% Conversion
No. of 483’s Issued
6
Warning Letters Issued
0
Countries Inspected
USA
FDA Investigators having one site common
Detailed Analysis
Approach:
Fadden tends to adhere strictly to the FDA guidelines, especially GMP standards. She is thorough, always checking for compliance with documentation requirements, proper investigation of any discrepancies, and appropriate training of all personnel.
Profile:
Auditor Marie A Fadden is meticulous and methodical with a specific focus on Good Manufacturing Practices (GMP). She shows a particular interest in proper documentation procedures, staff training, and thorough investigations of abnormalities. Her observations indicate a heavy emphasis on Quality Control (QC) procedures and need for the thoroughness in investigations when non-compliance occurs.
Top Process Types:
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
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