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

Source: https://www.keypedia.com/records/483/lgm-pharma-solutions-llc/0f59dd4a-490d-41b1-a687-2ef6fdeacee1

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

---

## Details

- Record Type: 483
- Company Name: LGM Pharma Solutions, LLC
- Inspection Date: 2024-03-01
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of LGM Pharma Solutions, LLC, conducted from February 21 to March 1, 2024, identified significant deficiencies in the company's adherence to Current Good Manufacturing Practices (cGMP). Key violations centered on inadequate quality control unit procedures, production process controls, laboratory data integrity, and equipment cleaning protocols. Specifically, the quality control unit lacked written procedures for comprehensive oversight, including managing production deviations, tracking facility excursions, and performing annual data audits, with one instance highlighting an unaddressed API contamination risk. Production issues included operators handling in-process materials with uncleaned gloves, creating a contamination risk. In the laboratory, unauthorized sample retesting and incomplete data recording were observed without proper deviation documentation. Furthermore, equipment cleaning procedures were not consistently followed or adequately documented, exemplified by a visibly soiled scoop stored in a ready-to-use area and insufficient sanitation of raw material containers. LGM Pharma Solutions, LLC is required to implement thorough corrective and preventive actions to rectify these observations and ensure compliance with regulatory standards for drug product safety, identity, strength, purity, and quality.

## Related Documents

- [483 - 2024-03-01](https://www.keypedia.com/records/483/lgm-pharma-solutions-llc/fbc5e811-568b-41cb-9541-fed0314350c7)

## Related Officers

- [Professor of Medicine](https://www.keypedia.com/people/lawrence-r-deyton/92881ee2-c62d-4faf-b619-4900022cc779)
- [Program Division Director](https://www.keypedia.com/people/randy-f-pack/c4e89614-5aa6-4d3f-90dc-68482b499967)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b