# FDA 483 - Frantz Medical Development Ltd - June 27, 2023

Source: https://www.globalkeysolutions.net/records/483/frantz-medical-development-ltd/68b41ccc-31f7-4dbb-932c-e648c6386a91

> FDA 483 for Frantz Medical Development Ltd on June 27, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Frantz Medical Development Ltd
- Inspection Date: 2023-06-27
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Frantz Medical Development Ltd, a medical device manufacturer in Mentor, OH, was cited for significant deficiencies in its quality system. Observations include inadequate corrective and preventive action procedures and documentation, lack of established statistical techniques for process control, and missing procedures for nonconforming product rework. Additionally, the firm failed to fully document process revalidation and released products without completing necessary qualifications.

## Related Documents

- [483 - 2018-09-24](https://www.globalkeysolutions.net/records/483/frantz-medical-development-ltd/ab668e2b-71ea-4136-b9e3-0cd07ea34525)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.globalkeysolutions.net/companies/frantz-medical-development-ltd/745bc436-afd1-4c94-b0f8-eb8c62353083

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