This guidance was initially intended for Third Party processors and Hospitals with FDA expected to evaluate "other establishments" later. It has been 15-17 years... anyone know where they are at in this process? Are "other establishments" expected to comply now as well? I've even reached out to the authors for clarification, but no luck, as in no response.
Thank you,
Gretchen
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Gretchen Upton RAC
RA/QA
TX
United States
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