# FDA 483 - LGM Pharma LLC - April 08, 2022

Source: https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/91297ae6-fb36-4023-978e-58e9b301f0ea

> FDA 483 for LGM Pharma LLC on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LGM Pharma LLC
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: LGM Pharma LLC, an Active Pharmaceutical Ingredient Distributor in Erlanger, KY, was cited for significant quality system deficiencies during an FDA inspection from March to April 2022. The firm failed to adequately investigate customer complaints and critical deviations, leading to potential distribution of compromised products. Additionally, the inspection revealed issues with recording quality activities and proper vendor qualification and oversight.

## Related Documents

- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/a56f4cf6-83f2-4b3f-8534-13450b859080)
- [483 - 2024-06-28](https://www.globalkeysolutions.net/records/483/lgm-pharma-llc/736cb79a-d2a0-4a5a-9ade-0d88191bfcb4)

## Related Officers

- [Anna M. Brannen](https://www.globalkeysolutions.net/people/anna-m-brannen/b8513ae4-9182-4024-94e4-dea1da4341be)
- [Joseph A. Paolocks](https://www.globalkeysolutions.net/people/joseph-a-paolocks/aa0bd3b7-504c-4c1f-a574-c9b29836b78a)
- [Jazmine N. Brown](https://www.globalkeysolutions.net/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

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