# FDA 483 - Corbin Clinical Resources, Llc - December 01, 2023

Source: https://www.keypedia.com/records/483/corbin-clinical-resources-llc/f64b3f91-8aaa-4eb6-92f5-90d83acd674d

> FDA 483 for Corbin Clinical Resources, Llc on December 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corbin Clinical Resources, Llc
- Inspection Date: 2023-12-01
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Corbin Clinical Resources, Llc, a medical device manufacturer in Cumberland, MD, was cited by the FDA for not adequately establishing procedures for design input. The inspection revealed discrepancies between the intended use defined in design records and device clearance letters for their PrecisionPoint® Biopsy Needle Guide and Perineologic™ Access Needle devices. Additionally, a claimed storage temperature on device labeling was not verified or validated.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/corbin-clinical-resources-llc/cc6f3175-4f20-4543-b7d9-b6f650148936

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64