# FDA 483 - Sharps Compliance, Inc. - January 31, 2023

Source: https://www.globalkeysolutions.net/records/483/sharps-compliance-inc/961268b2-1789-4c3a-8ec2-c4f6b0ee4d56

> FDA 483 for Sharps Compliance, Inc. on January 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharps Compliance, Inc.
- Inspection Date: 2023-01-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Sharps Compliance, Inc. in Houston, TX, a medical device manufacturer, received a Form FDA-483 with nine observations following an inspection. The findings highlight significant deficiencies in the firm's quality system, including inadequate documentation for complaint investigations, CAPA activities, and nonconforming product control. Additionally, issues were noted with procedures for labeling, acceptance activities, sampling methods, device history records, and design changes.

## Related Documents

- [483 - 2024-01-19](https://www.globalkeysolutions.net/records/483/sharps-compliance-inc/a2ebb7b8-a25a-47f8-bc00-4e1b41a54df2)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

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