FDA 483 - Alcami Carolinas Corporation - March 28, 2025
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An FDA inspection of Alcami Carolinas Corporation in Morrisville, NC, resulted in a Form 483 with four observations. The firm was cited for significant deficiencies in its quality control unit procedures, inadequate written procedures for equipment cleaning and maintenance, and a lack of a written program for drug product stability testing. Additionally, the company failed to establish appropriate time limits for various production phases to ensure drug product quality.
ID · 73f43ecd-92e3-495c-924f-dc36791e75d3