# FDA 483 - GEM City Enginnering and Manufacturing Corporation - March 01, 2018

Source: https://www.globalkeysolutions.net/records/483/gem-city-enginnering-and-manufacturing-corporation/c074bd1a-1328-4fa9-85a6-76abe5fc5dbf

> FDA 483 for GEM City Enginnering and Manufacturing Corporation on March 01, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GEM City Enginnering and Manufacturing Corporation
- Inspection Date: 2018-03-01
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: GEM City Engineering and Manufacturing Corporation, a contract manufacturer in Dayton, OH, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight systemic failures in document control, corrective and preventive actions, production processes, finished device acceptance, complaint handling, nonconforming product control, device history records, and process validation. These issues indicate a broad lack of established and followed procedures essential for ensuring device quality and regulatory compliance.

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/gem-city-enginnering-and-manufacturing-corporation/d74628bb-6a58-403e-8548-143e058ae422

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