# FDA 483 - Alltech Medical Systems America Inc - July 29, 2019

Source: https://www.globalkeysolutions.net/records/483/alltech-medical-systems-america-inc/a0180e87-dc14-4628-b42b-4ff5b977b215

> FDA 483 for Alltech Medical Systems America Inc on July 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alltech Medical Systems America Inc
- Inspection Date: 2019-07-29
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Alltech Medical Systems America Inc, a medical device manufacturer in Solon, OH, was inspected by the FDA. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, complaint handling, servicing activities, nonconforming product control, supplier management, and design verification and validation. These issues indicate a systemic lack of robust quality management practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/alltech-medical-systems-america-inc/239def2e-4814-4f48-91a6-c5498cc93e40

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