# FDA 483 - SCIARRA AEROMED, INC - February 25, 2026

Source: https://www.keypedia.com/records/483/sciarra-aeromed-inc/f477989c-b486-4342-ac28-0b57a143459a

> FDA 483 for SCIARRA AEROMED, INC on February 25, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCIARRA AEROMED, INC
- Inspection Date: 2026-02-25
- Product Type: other
- Office Name: New England District Office
- Summary: Sciarra Aeromed Inc. in Carmel, NY, was inspected regarding its manufacturing of sterile medical products. The inspection revealed significant deficiencies in aseptic processing controls, including inadequate process validation, personnel and environmental monitoring, cleaning procedures, and air quality monitoring, indicating a lack of control over the sterile manufacturing environment.

## Related Documents

- [483 - 2026-02-25](https://www.keypedia.com/records/483/sciarra-aeromed-inc/f3fc5f57-9af5-4769-969a-67a1b5b0f7db)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)

Company: https://www.keypedia.com/companies/sciarra-aeromed-inc/1280a2d7-ab5f-43e3-bb6b-72b7aeb4b18d

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144