# FDA 483 - Sharps Compliance, Inc. - January 19, 2024

Source: https://www.globalkeysolutions.net/records/483/sharps-compliance-inc/a2ebb7b8-a25a-47f8-bc00-4e1b41a54df2

> FDA 483 for Sharps Compliance, Inc. on January 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharps Compliance, Inc.
- Inspection Date: 2024-01-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Sharps Compliance, Inc. in Houston, TX, a specification developer, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures and implementation regarding design changes, complaint handling, and supplier controls. These issues are particularly concerning as several observations were repeats from a previous inspection.

## Related Documents

- [483 - 2023-01-31](https://www.globalkeysolutions.net/records/483/sharps-compliance-inc/961268b2-1789-4c3a-8ec2-c4f6b0ee4d56)

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/sharps-compliance-inc/6c80e3b6-ba62-4c60-853d-10a0df067fcc

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