# FDA 483 - Health Science Products Inc - August 23, 2019

Source: https://www.keypedia.com/records/483/health-science-products-inc/3f4cb951-73bd-4fee-9b8b-571589710e26

> FDA 483 for Health Science Products Inc on August 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Science Products Inc
- Inspection Date: 2019-08-23
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Health Science Products Inc, a medical device manufacturer in Hueytown, AL, revealed numerous significant deficiencies in its quality system. The firm failed to establish and implement essential procedures for medical device reporting, corrective and preventive actions, and complaint handling. Additionally, the inspection found a lack of proper maintenance for device master records, device history records, purchasing controls, quality audits, and management reviews, indicating a broad failure to comply with quality system requirements.

## Related Documents

- [WARNING_LETTER - 2011-08-10](https://www.keypedia.com/records/warning_letter/health-science-products-inc/efe840a9-1dcb-4588-8a7e-96ff1aee9be6)
- [WARNING_LETTER - 2014-01-23](https://www.keypedia.com/records/warning_letter/health-science-products-inc/c8013d7a-2874-44c3-9808-695d087014c2)

## Related Officers

- [Wendy Blame](https://www.keypedia.com/people/wendy-blame/2514a5b1-51fe-4b91-b79b-6d3eb0b9a566)

Company: https://www.keypedia.com/companies/health-science-products-inc/980eb62e-99cd-4b3a-b504-8470f9d92359

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea