# FDA 483 - Frantz Medical Development Ltd - September 24, 2018

Source: https://www.globalkeysolutions.net/records/483/frantz-medical-development-ltd/ab668e2b-71ea-4136-b9e3-0cd07ea34525

> FDA 483 for Frantz Medical Development Ltd on September 24, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frantz Medical Development Ltd
- Inspection Date: 2018-09-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Frantz Medical Development Ltd, a medical device manufacturer in Mentor, OH, was cited with five observations during an FDA inspection. The observations primarily concern inadequately established procedures across several critical quality system areas, including CAPA, complaint handling, non-conforming product control, supplier management, and process validation. The firm's quality system appears to lack robust processes for data analysis, risk management integration, and clear operational definitions.

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## 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