# FDA 483 - PROSPECT LIFE SCIENCES - November 17, 2022

Source: https://www.keypedia.com/records/483/prospect-life-sciences/05a28a30-3d16-4d5b-9f3f-844193a3c6fe

> FDA 483 for PROSPECT LIFE SCIENCES on November 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PROSPECT LIFE SCIENCES
- Inspection Date: 2022-11-17
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of PROSPECT LIFE SCIENCES, a medical device contract manufacturer in Westminster, CO, revealed two significant observations. The firm was cited for inadequate documentation of corrective and preventive action (CAPA) activities, specifically regarding root cause investigations and verification of effectiveness. Additionally, the inspection found deficiencies in the company's procedures for receiving, reviewing, and evaluating product complaints, including a lack of requirements to review relevant quality data sources during investigations.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/prospect-life-sciences/62bdda21-c05b-4f0f-8cbf-fe8e1f0ff461

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face