# FDA 483 - Altor Safety - March 12, 2026

Source: https://www.keypedia.com/records/483/altor-safety/f3c5ee6b-a7bc-4f65-ac3b-abcef8157ad9

> FDA 483 for Altor Safety on March 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Altor Safety
- Inspection Date: 2026-03-12
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Altor Safety, a manufacturer of surgical masks in Valley Cottage, NY, revealed significant deficiencies in its quality management system. The firm failed to document essential procedures, maintain required device and design files, validate manufacturing processes, and establish procedures for reporting adverse events. These observations indicate a broad lack of compliance with medical device regulatory requirements.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/altor-safety/0f2af77b-17a2-40d4-a0fe-be65b71ed6cc

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d