# FDA 483 - Gener8 - May 05, 2023

Source: https://www.globalkeysolutions.net/records/483/gener8/5f292c3f-2e4b-4df1-a259-bb6016d77221

> FDA 483 for Gener8 on May 05, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gener8
- Inspection Date: 2023-05-05
- Product Type: other
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Gener8, a contract manufacturer in San Jose, CA, from May 2-5, 2023, revealed a significant issue with their quality system. The firm's procedures for servicing products and conducting failure analysis investigations were found to be inadequately defined. Specifically, 5 out of 6 reviewed Returned Material Authorization (RMA) investigations lacked proper documentation.

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.globalkeysolutions.net/companies/gener8/bc8384a9-3f8f-44f1-9960-40f550abbb96

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df