FDA 483 - Allay Pharmaceuticals, LLC - November 15, 2021

An FDA inspection of Allay Pharmaceuticals, LLC in Miami Gardens, FL, a drug manufacturer, revealed significant deficiencies in their quality control unit procedures and master production records. The firm's written procedures for complaint handling, adverse event reporting, and raw material sampling were found to be incomplete, contain inapplicable requirements, or not be fully followed. Additionally, master batch records for NP Thyroid tablets lacked complete manufacturing and sampling instructions.