# FDA 483 - Hospital Therapy Products Inc. - May 14, 2019

Source: https://www.keypedia.com/records/483/hospital-therapy-products-inc/6b10e68a-23fa-4065-8228-ef87449feaa6

> FDA 483 for Hospital Therapy Products Inc. on May 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospital Therapy Products Inc.
- Inspection Date: 2019-05-14
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Hospital Therapy Products Inc. in Wood Dale, IL, was inspected by the FDA from May 7-14, 2019, and received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in establishing quality audits, documenting CAPA activities, defining quality policy and plans, establishing management review procedures, and ensuring proper document control. Several observations were repeats from previous inspections, indicating persistent issues.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)
- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/hospital-therapy-products-inc/794cedad-8eb8-4aeb-b31f-f5c6c38096d6

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669