483
Pharmalogic Austin LLCFDA 483 - Pharmalogic Austin LLC - November 21, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 23e439a4-bd06-471b-8a22-4c7e466e0ade