# FDA 483 - Microvascular Tissue, Inc - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/microvascular-tissue-inc/f8d3d9c1-9f7f-4aad-8854-272921f824a7

> FDA 483 for Microvascular Tissue, Inc on April 08, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microvascular Tissue, Inc
- Inspection Date: 2025-04-08
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Microvascular Tissue, Inc. in San Diego, CA, revealed significant deficiencies in their quality system for the biological product mVASC. Observations included inadequate complaint investigations, unvalidated manufacturing processes, and a lack of identity testing for drug product components. The firm also failed to thoroughly review batches that did not meet specifications.

## Related Documents

- [WARNING_LETTER - 2025-04-08](https://www.globalkeysolutions.net/records/warning_letter/microvascular-tissue-inc/2f306808-3588-4226-a925-b484598e1e1d)

## Related Officers

- [Garrad R. Poole](https://www.globalkeysolutions.net/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/microvascular-tissue-inc/f7439e2a-45e9-4870-86dd-46af3dbd3cf4

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b