Glossary
Stephen C Smith
FDA Investigator Details
Stephen C Smith
Visit Investigator ProfileInvestigation Details
Last Issued Date
December 29, 2015
Conversion Rate
0
% Conversion
No. of 483’s Issued
2
Warning Letters Issued
0
Countries Inspected
USA
FDA Investigators having one site common
Detailed Analysis
Approach:
Investigator Smith prioritizes adherence to regulatory standards and mandates thoroughly. He is particularly interested in the correct implementation of MDR procedures which ensures patient safety.
Profile:
FDA investigator Stephen C Smith shows a keen interest in regulatory compliance, particularly related to medical device reporting (MDR). Based on his prior inspections, a pattern can be identified that he is meticulous and strict when scrutinizing hospitals' MDR procedures and policies. He frequently identifies omissions or delays in required MDR submissions along with a lack of proper MDR documentation.
Top Process Types:
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
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