# FDA 483 - LGM Pharma Solutions, LLC - March 01, 2024

Source: https://www.keypedia.com/records/483/lgm-pharma-solutions-llc/fbc5e811-568b-41cb-9541-fed0314350c7

> FDA 483 for LGM Pharma Solutions, LLC on March 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LGM Pharma Solutions, LLC
- Inspection Date: 2024-03-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: LGM Pharma Solutions, LLC in Irvine, CA, received a Form FDA 483 with four observations following an inspection from February 21 to March 1, 2024. The inspection revealed significant deficiencies in the firm's quality control unit procedures, production and process controls, laboratory data integrity, and equipment cleaning and maintenance. These issues indicate a lack of adequate controls to ensure drug product quality and purity.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

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