# ONY Biotech, Inc. - Inspection Records

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

> Inspection records and compliance data for ONY Biotech, Inc. in Amherst, New York. Access full analysis and detailed observations.

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## Details

- Name: ONY Biotech, Inc.
- FEI Number: 1319086
- City: Amherst
- State: New York
- Country Name: United States
- Address Line 1: 455 Commerce Dr
- Zip Code: 14228

## Related Documents

- [483 - ONY Biotech, Inc. - 2026-02-05](https://www.keypedia.com/records/483/ony-biotech-inc/5f77d626-2462-4295-8c7e-65931d243887) — source: FDA, date: February 5, 2026
- [FDA Inspection 1301388 - ONY Biotech, Inc. - 2026-02-05](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/1a72f1f8-4ab4-4eb7-8fc5-58ded428e2b7) — source: FDA, date: February 5, 2026
- [483 - ONY Biotech, Inc. - 2024-09-26](https://www.keypedia.com/records/483/ony-biotech-inc/38785bed-8077-4171-910d-ca2a89915509) — source: FDA, date: September 26, 2024
- [FDA Inspection 1250105 - ONY Biotech, Inc. - 2024-09-26](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/3f2477de-996c-40dc-bed9-80bdd712a317) — classification: Official Action Indicated (OAI), source: FDA, date: September 26, 2024
- [FDA Inspection 1005033 - ONY Biotech, Inc. - 2017-03-02](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/b46b9d20-ad72-43f6-9b07-52649c2fe72b) — classification: No Action Indicated (NAI), source: FDA, date: March 2, 2017
- [FDA Inspection 946338 - ONY Biotech, Inc. - 2015-10-09](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/0e0d2c58-3e0d-4bc0-9bf5-1377100e6f85) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 9, 2015
- [FDA Inspection 830440 - ONY Biotech, Inc. - 2013-04-25](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/7c7ec6f4-5a12-4a2b-8787-b312c11f535b) — classification: No Action Indicated (NAI), source: FDA, date: April 25, 2013
- [FDA Inspection 830440 - ONY Biotech, Inc. - 2013-04-25](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/4ec53d44-6015-457a-b9bc-e3f86b11751e) — classification: No Action Indicated (NAI), source: FDA, date: April 25, 2013
- [FDA Inspection 748464 - ONY Biotech, Inc. - 2011-10-06](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/1a7b24fb-1f68-478d-8fd1-6fff8c0d7192) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 6, 2011
- [FDA Inspection 697520 - ONY Biotech, Inc. - 2010-11-09](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/9e44c1cf-17a3-45f1-bb8f-cf4ff01f7711) — classification: No Action Indicated (NAI), source: FDA, date: November 9, 2010
- [FDA Inspection 631821 - ONY Biotech, Inc. - 2009-12-03](https://www.keypedia.com/records/fda_inspections/ony-biotech-inc/35c3c749-591a-456f-b24b-314b3f503d56) — classification: No Action Indicated (NAI), source: FDA, date: December 3, 2009

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## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Armen H. Youssoufian](https://www.keypedia.com/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)
- [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)
