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On-demand FDA inspection records

FDA Inspection Documents

On-demand, a la carte access to the regulatory intelligence you need for your upcoming FDA inspection — 483s, 483 responses, and EIRs.

Form 483s

FDA inspection observations issued to companies

483 Responses

Company responses to FDA observations

EIRs

Establishment Inspection Reports

12,400+
Documents available
1,900+
FDA inspectors indexed
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Recent FDA Inspectors

Xikui Chen
FDA Investigator
Zhaoyang Meng
FDA Investigator
Kenneth H. Williams
FDA Investigator
Zhigang Sun
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Tsedenia Woldehanna
FDA Investigator
Pei-I Chu
FDA Investigator
Monica C. Burgos Garcia
FDA Investigator
Kejun Cheng
FDA Investigator
Burgos Garcia, Monica C
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Lei Zhang
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Joseph M. Edwin
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Peter M. Trunk
FDA Investigator
Mercedes G. Castillo
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Winston R. Alejo
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Joyce A. Williams
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Brandon J. Brookens
FDA Investigator
Michael J. Mero
FDA Investigator
Jason M. Sluzynski
FDA Investigator
John M. Mastalski
FDA Investigator
Donald W. Myrick
FDA Investigator
Wendy M. Stark
FDA Investigator
Jeen S. Min
FDA Investigator
Frank Verni
FDA Investigator
Benjamin J. Smith
FDA Investigator
Jorge L. Guadalupe
FDA Investigator