# FDA 483 - BioMed ENT, Inc - June 24, 2025

Source: https://www.keypedia.com/records/483/biomed-ent-inc/d77884ad-0c6b-488d-bb65-7805009bd73d

> FDA 483 for BioMed ENT, Inc on June 24, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMed ENT, Inc
- Inspection Date: 2025-06-24
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: BioMed ENT, Inc. in Milwaukee, WI, was inspected regarding its HCT/P-Ambient Warehouse operations. The inspection revealed significant deficiencies in record-keeping for human tissue product storage temperatures and equipment calibration. Additionally, the firm failed to establish, maintain, and follow appropriate procedures for manufacturing and distribution activities, indicating a lack of adherence to core CGTP requirements.

## Related Officers

- [Amy A. Johnson](https://www.keypedia.com/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.keypedia.com/companies/biomed-ent-inc/51e1f90c-5729-4ba5-b60a-3f4bdb53b972

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d