# FDA 483 - LGM Pharma LLC - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/736cb79a-d2a0-4a5a-9ade-0d88191bfcb4

> FDA 483 for LGM Pharma LLC on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LGM Pharma LLC
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: LGM Pharma LLC, a distributor in Erlanger, KY, was cited for significant deficiencies in its quality system related to supplier management. The inspection revealed inadequate qualification of API suppliers, including a failure to perform onsite audits and premature approval of manufacturers. Additionally, the firm lacked written procedures for external audits and failed to qualify third-party auditors.

## Related Documents

- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/a56f4cf6-83f2-4b3f-8534-13450b859080)
- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/91297ae6-fb36-4023-978e-58e9b301f0ea)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.globalkeysolutions.net/companies/lgm-pharma-llc/45c8af36-9473-4ceb-8fd3-e3fd9c24582f

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22