FDA 483 - Pharmalogic Austin LLC - November 21, 2024

Pharmalogic Austin LLC, a drug product manufacturer in Austin, TX, received a Form 483 with five observations related to significant deficiencies in their quality control and production systems. The observations highlight issues with stability testing programs, component identity testing, equipment suitability, and critical documentation within batch production records, indicating a need for improved adherence to cGMP regulations.