# FDA 483 - LGM Pharma, LLC - April 14, 2022

Source: https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/c757d8b7-0b68-4155-8d4a-1d3796e23694

> FDA 483 for LGM Pharma, LLC on April 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LGM Pharma, LLC
- Inspection Date: 2022-04-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations Central
- Summary: LGM Pharma, LLC in Boca Raton, FL, was issued a Form 483 with two observations following an FDA inspection. The firm's quality system was found deficient, specifically regarding its vendor qualification procedures and the investigation of deviations. These issues indicate a lack of adequate control over the quality and status of active pharmaceutical ingredients (APIs) and their suppliers.

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.globalkeysolutions.net/companies/lgm-pharma-llc/7e687603-5df5-4f70-997d-70db36680943

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-operations-central/fdd6d0ca-6039-4ac5-8989-2b0514b056f0