Inspections, Compliance, Enforcement, and Criminal Investigations

10-5 - ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS AND DECISIONS

For further information related to "EIR Conclusions and Decisions," see Field Management Directive No. 86, or refer to the web site at http://www.fda.gov/downloads/iceci/inspections/fieldmanagementdirectives/ucm382035.pdf.

Please remember to update the firm's FACTS profile information at each stage in the review process to its conclusion, as appropriate, for any Current Good Manufacturing Practice (CGMP) or Quality System (QS) inspection of a domestic or foreign drug, biologics, or medical device facility that involves compliance activity or status. See "Firm Profile Updates in FACTS" in Chapter 4 for further information.

Page Last Updated: 04/05/2016
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