# FDA 483 - Mediwest Specialty Distribution LLC - December 20, 2022

Source: https://www.globalkeysolutions.net/records/483/mediwest-specialty-distribution-llc/932c5a0e-2539-48a5-ba6a-c377d9048e57

> FDA 483 for Mediwest Specialty Distribution LLC on December 20, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mediwest Specialty Distribution LLC
- Inspection Date: 2022-12-20
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Mediwest Specialty Distribution LLC in Hormigueros, PR, an HT Warehouse, revealed significant deficiencies in their operations. The firm failed to establish and implement critical procedures for the storage, handling, distribution, and complaint management of human tissue products. These failures indicate a lack of adherence to good tissue practices.

## Related Officers

- [Laura E. Garcia](https://www.globalkeysolutions.net/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.globalkeysolutions.net/companies/mediwest-specialty-distribution-llc/29f7f9ad-7973-464d-b361-18cb82c35333

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6