# FDA 483 - Biomat Holdings Mount Vernon Newark - July 15, 2025

Source: https://www.globalkeysolutions.net/records/483/biomat-holdings-mount-vernon-newark/c398a263-3549-4d2b-830e-a868c8055866

> FDA 483 for Biomat Holdings Mount Vernon Newark on July 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat Holdings Mount Vernon Newark
- Inspection Date: 2025-07-15
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Biomat Holdings Mount Vernon Newark in Newark, OH, identified a significant concern regarding phlebotomy site preparation. Inspectors observed phlebotomists palpating venipuncture sites after needle insertion, which compromises the sterile field. This practice raises concerns about the sterility of collected source plasma units and adherence to proper aseptic technique.

## Related Officers

- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.globalkeysolutions.net/companies/biomat-holdings-mount-vernon-newark/69296c4e-ea7e-4ad9-b744-434f490513cd

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22