# FDA 483 - ONY Biotech, Inc. - February 05, 2026

Source: https://www.keypedia.com/records/483/ony-biotech-inc/5f77d626-2462-4295-8c7e-65931d243887

> FDA 483 for ONY Biotech, Inc. on February 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONY Biotech, Inc.
- Inspection Date: 2026-02-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: ONY Biotech, Inc., an API and sterile drug manufacturer in Amherst, NY, was cited for significant deficiencies in quality control and manufacturing processes. The inspection revealed failures to thoroughly investigate discrepancies and microbial excursions, inadequate procedures for preventing microbiological contamination of sterile products, and unauthorized changes to temperature monitoring without proper documentation. These issues indicate a lack of robust quality systems and control over critical manufacturing steps.

## Related Documents

- [483 - 2024-09-26](https://www.keypedia.com/records/483/ony-biotech-inc/38785bed-8077-4171-910d-ca2a89915509)

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Lauren H. Augustyniak](https://www.keypedia.com/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)
- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.keypedia.com/companies/ony-biotech-inc/a2997e30-1b39-4dea-9fec-a960aafcefd0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961