# FDA 483 - LCC Medical Research Institute, LLC - September 13, 2019

Source: https://www.keypedia.com/records/483/lcc-medical-research-institute-llc/fe83161c-c6c4-432b-8a18-e37275895ff3

> FDA 483 for LCC Medical Research Institute, LLC on September 13, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LCC Medical Research Institute, LLC
- Inspection Date: 2019-09-13
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of LCC Medical Research Institute, LLC. in Miami, FL, conducted from September 10-13, 2019, identified a significant issue regarding the storage of retention samples. The firm failed to properly store these samples on-site or with an independent third-party, instead compromising their integrity by initially shipping them to the test article packager/labeler. This practice raises concerns about the proper handling and control of critical study materials.

## Related Officers

- [Angelica M. Chica](https://www.keypedia.com/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)

Company: https://www.keypedia.com/companies/lcc-medical-research-institute-llc/279828b6-2978-4aa5-9c5d-773ede5adf2a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6