State device inspection contracts to be modified to include recent FDA initiatives.
This article was originally published in The Gray Sheet
Executive Summary
STATE DEVICE INSPECTION CONTRACT REVISIONS WILL ADD PREANNOUNCED AUDITS, annotated 483s, and post-inspection letters to the program. FDA is planning to amend its device facility inspection contracts with California, Colorado and Texas to include changes to auditing procedures that the agency implemented on a permanent basis in March ("The Gray Sheet" March 24, p. 6).
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