# FDA 483 - You First Services, Inc. - December 18, 2023

Source: https://www.globalkeysolutions.net/records/483/you-first-services-inc/f9edb071-f2e8-4dcb-a0aa-722f6e73272b

> FDA 483 for You First Services, Inc. on December 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: You First Services, Inc.
- Inspection Date: 2023-12-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: You First Services, Inc., a medical device manufacturer in Buffalo, NY, received a Form FDA-483 with five observations following an inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, insufficient complaint handling, and non-compliance with Unique Device Identification (UDI) requirements for labeling and database submission. Additionally, the firm failed to adequately document personnel training for critical manufacturing processes.

## Related Documents

- [483 - 2021-05-21](https://www.globalkeysolutions.net/records/483/you-first-services-inc/aec4d859-d050-46b2-aa59-c817410597f5)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/you-first-services-inc/b16a9dcc-abee-450f-abc0-57941b5165c2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961