FDA 483 - Pharmalogic Austin LLC - November 21, 2024

From November 18-21, 2024, the FDA inspected Pharmalogic Austin LLC, a drug product manufacturer located at 10600 N Lamar Blvd, Austin, TX 78753. The inspection, conducted by Laurimer Kuilan-Torres and Laurie Nelson, resulted in five observations documented on Form FDA 483, issued to Ashley E. Mishoe, Vice President, Regulatory Affairs and Quality Assurance.

Key observations include:

1. **Laboratory Control System:** The firm lacked a written testing program for assessing stability characteristics of [REDACTED] drug products. Specifically, the Annual Stability Testing Form Q809 did not include all annual stability testing per [REDACTED] commitments and lacked details like storage temperature and temperature monitoring.

2. **Material System:** Identity testing was not conducted on each lot of component yielding an active ingredient in [REDACTED] drug products where finished product testing did not ensure correct component use. Identification testing for the critical component [REDACTED] precursor was not specified at receipt.

3. **Facilities and Equipment System:** Procedures were not implemented to ensure equipment suitability. * No scientific rationale supported the [REDACTED] product delivery line practice for clearing impurities. * The environmental monitoring procedure (SOP Q047 V12) for contact and settling plate testing was deficient, lacking scientific rationale for worst-case