ONY Biotech Inc.
Form 483 issued September 26, 2024 · Amherst, New York
- Inspection
- Sep 16 – Sep 26, 2024
- Investigators
- Armen H. Youssoufian· Sean R. Marcsisin
- Observations
- 11
- Pages
- 13
- FEI number
- 1319086
In short: On September 26, 2024, FDA issued a Form 483 with 11 observations to ONY Biotech Inc. in Amherst, New York (FEI 1319086) after an inspection that ran Sep 16 – Sep 26, 2024. The investigators were Armen H. Youssoufian and Sean R. Marcsisin. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 8 of 11 observations.
Most cited: FDCA 582(b)(4) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmONY Biotech Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ONY Biotech Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected ONY Biotech Inc.?
Armen H. Youssoufian and Sean R. Marcsisin are named on this Form 483, for the inspection of Sep 16 – Sep 26, 2024. Each investigator has a profile showing what they cite most.
When was ONY Biotech Inc. inspected by FDA?
The inspection ran Sep 16 – Sep 26, 2024, and the Form 483 is dated September 26, 2024.
How do I get the full Form 483 for ONY Biotech Inc.?
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