# FDA 483 - Pharmalogic Austin LLC - November 21, 2024

Source: https://www.keypedia.com/records/483/pharmalogic-austin-llc/b8505fb2-5087-46bb-b78b-6fa67267c0f1

> FDA 483 for Pharmalogic Austin LLC on November 21, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalogic Austin LLC
- Inspection Date: 2024-11-21
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Manufacturing Assessment
- Summary: 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

## Related Documents

- [483 - 2024-11-21](https://www.keypedia.com/records/483/pharmalogic-austin-llc/23e439a4-bd06-471b-8a22-4c7e466e0ade)

## Related Officers

- [Laurimer X. Kauian-Torres](https://www.keypedia.com/people/laurimer-x-kauian-torres/0be42c7a-e6c6-435e-bf56-74ca7fe413ec)
- [Laurie A. Nelson](https://www.keypedia.com/people/laurie-a-nelson/dbd373d1-ce1f-486c-a932-d93f8f52832d)

Company: https://www.keypedia.com/companies/pharmalogic-austin-llc/e2abd60d-e394-410e-8e98-a7a651ddf3df

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df