# FDA 483 - Biomat USA, Inc. - June 18, 2025

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/c4f0de6a-f29b-4578-90c8-e24b0ce50318

> FDA 483 for Biomat USA, Inc. on June 18, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomat USA, Inc.
- Inspection Date: 2025-06-18
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of DB Biologics, LLC in Harrisburg, PA, a source plasma donor center, revealed a significant issue regarding the preparation of phlebotomy sites. The firm failed to ensure sterile venipuncture sites for donor blood collections, as phlebotomists were observed palpating prepared areas before proceeding with collections. This practice compromises the sterility of blood products.

## Related Officers

- [Michele Gottshall](https://www.globalkeysolutions.net/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/3c9739bc-e5fb-436c-b0ef-9b6e14354a7d

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8