# FDA 483 - Pharmalogic Los Angeles, LLC - February 05, 2026

Source: https://www.keypedia.com/records/483/pharmalogic-los-angeles-llc/f616832d-321c-4b48-9c6a-176290745154

> FDA 483 for Pharmalogic Los Angeles, LLC on February 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalogic Los Angeles, LLC
- Inspection Date: 2026-02-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of PharmaLogic Los Angeles, LLC, a manufacturer of PET drugs, revealed a significant deficiency in their quality system. The firm failed to approve or reject processes and procedures before implementation, specifically regarding the visual inspection of PET drug products. This issue raises concerns about the adequacy of operator training and the ability to detect defects, potentially impacting drug identity, strength, quality, and purity.

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)
- [Joey Y Quintana](https://www.keypedia.com/people/joey-y-quintana/f90686f9-accd-4034-825e-0adbd9203ff6)
- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)

Company: https://www.keypedia.com/companies/pharmalogic-los-angeles-llc/417391fc-7718-4078-9ef6-37bcae858bc1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6