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

Source: https://www.keypedia.com/records/483/pharmalogic-austin-llc/23e439a4-bd06-471b-8a22-4c7e466e0ade

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

---

## Details

- Record Type: 483
- Company Name: Pharmalogic Austin LLC
- Inspection Date: 2024-11-21
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: 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.

## Related Documents

- [483 - 2024-11-21](https://www.keypedia.com/records/483/pharmalogic-austin-llc/b8505fb2-5087-46bb-b78b-6fa67267c0f1)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)
- [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/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9