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FDA inspections

This article was originally published in The Gray Sheet

Executive Summary

Post-inspection notification (PIN) letters will no longer be issued once an inspection is deemed closed under policy change effective Jan. 1. Establishments will be notified that an inspection is closed by receipt of a copy of FDA's Establishment Inspection Report (EIR), which the agency began providing to all inspected establishments in April 1997. Because the EIR is accompanied by an "FMD 145" letter, the agency considers the additional PIN letter to be redundant. FDA's Office of Regulatory Affairs will continue its policies of pre-announced inspections and annotated Form 483s for all device inspections, a Jan. 4 Federal Register notice confirms
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