# FDA 483 - LGM Pharma Solutions, LLC - May 18, 2026

Source: https://www.keypedia.com/records/483/lgm-pharma-solutions-llc/3de1b8bb-d84a-44df-a320-9014410545f1

> FDA 483 for LGM Pharma Solutions, LLC on May 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LGM Pharma Solutions, LLC
- Inspection Date: 2026-05-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: LGM Pharma Solutions, LLC, a drug product and API manufacturer in Irvine, CA, received an FDA Form 483 citing significant deficiencies in its quality systems. Observations included inadequate production controls for managing product variability, deficient laboratory controls with outdated method validation, failure to thoroughly investigate recurring out-of-specification results, and non-compliance with annual reserve sample examination requirements. These findings indicate a need for comprehensive improvements in the firm's adherence to current Good Manufacturing Practices.

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## Related Officers

- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)
- [Journey V Cordero](https://www.keypedia.com/people/journey-v-cordero/caf484dc-3e04-42a0-a063-9b5fb184f47d)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Jay-Ar C. Bendo](https://www.keypedia.com/people/jay-ar-c-bendo/c920c6b7-756b-42c7-be52-8b677d192f77)
- [Devisree P. Mattigiri](https://www.keypedia.com/people/devisree-p-mattigiri/ecaf86a3-b2b0-4b07-907f-92632c3bbba9)

Company: https://www.keypedia.com/companies/lgm-pharma-solutions-llc/5ee22c42-8e6e-4af9-a2b7-832e0d586f19

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