# FDA 483 - Genesis Biosystems, Inc - January 09, 2023

Source: https://www.globalkeysolutions.net/records/483/genesis-biosystems-inc/215725ca-d209-4219-aa72-efaba79b09b1

> FDA 483 for Genesis Biosystems, Inc on January 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genesis Biosystems, Inc
- Inspection Date: 2023-01-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Genesis Biosystems, Inc., a medical device manufacturer in Lewisville, TX, received a Form FDA 483 with three observations during an inspection. The firm was cited for deficiencies in its complaint handling procedures, issues with internal audit independence, and inadequate supplier management records. Notably, one observation regarding supplier management was a repeat finding from a previous inspection.

## Related Documents

- [WARNING_LETTER - 2015-06-01](https://www.globalkeysolutions.net/records/warning_letter/genesis-biosystems-inc/b4aa67d6-a951-4ade-8cac-14d55d6e6524)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Terri E. Gibson](https://www.globalkeysolutions.net/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.globalkeysolutions.net/companies/genesis-biosystems-inc/3e6cf839-9bf8-4efa-ab65-d78786001597

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab