# FDA 483 - INDUCTION THERAPIES LLC - March 21, 2019

Source: https://www.globalkeysolutions.net/records/483/induction-therapies-llc/f1fffb77-235e-48d5-a083-68acfd706d84

> FDA 483 for INDUCTION THERAPIES LLC on March 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INDUCTION THERAPIES LLC
- Inspection Date: 2019-03-21
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of INDUCTION THERAPIES LLC in Louisville, KY, revealed significant deficiencies in the firm's quality system. The company failed to establish a quality policy, quality objectives, and a comprehensive quality plan. Furthermore, critical quality system procedures for areas such as management review, quality audits, CAPA, complaint handling, acceptance activities, and purchasing controls were either not developed or not implemented.

## Related Documents

- [483 - 2021-06-29](https://www.globalkeysolutions.net/records/483/induction-therapies-llc/99a7b990-96ad-438d-9d54-a666f6becae3)
- [483 - 2024-10-18](https://www.globalkeysolutions.net/records/483/induction-therapies-llc/c0bf52b5-388c-447a-8426-bb8da04bb5f0)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/induction-therapies-llc/da1784dc-8a3c-4fa7-a0b4-25db142806c4

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