# FDA 483 - LGM Pharma LLC - December 04, 2018

Source: https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/a56f4cf6-83f2-4b3f-8534-13450b859080

> FDA 483 for LGM Pharma LLC on December 04, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LGM Pharma LLC
- Inspection Date: 2018-12-04
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: LGM Pharma, LLC in Erlanger, Kentucky, an API relabeler, was cited for significant quality system deficiencies during an FDA inspection. Observations included improper relabeling of API products without testing, inadequate supplier qualification, and a dysfunctional quality unit. The firm also failed in complaint investigation, deviation management, recall procedures, product traceability, GMP training, storage conditions, and computer system validation, indicating a severe lack of control over critical pharmaceutical operations.

## Related Documents

- [483 - 2022-04-08](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/91297ae6-fb36-4023-978e-58e9b301f0ea)
- [483 - 2024-06-28](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/736cb79a-d2a0-4a5a-9ade-0d88191bfcb4)

## Related Officers

- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Program Analyst](https://www.globalkeysolutions.net/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

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