Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2026 – 5 Feb 2026 | Human Drugs | 483 | View 483 → |
| 16 Sep 2024 – 26 Sep 2024 | Human Drugs | 483 | View 483 → |
| 27 Feb 2017 – 2 Mar 2017 | Human Drugs | Clean | |
| 4 Oct 2015 – 9 Oct 2015 | Human Drugs | 483 | View 483 → |
| 23 Apr 2013 – 25 Apr 2013 | Human Drugs | Clean | |
| 6 Oct 2011 | Not recorded | 483 | On file |
| 9 Nov 2010 | Not recorded | Clean | |
| 3 Dec 2009 | Not recorded | Clean | |
| 11 Apr 2008 | Not recorded | Clean | |
| 20 Feb 2007 | Not recorded | Clean | |
| 30 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Gam S Zamil, Mindy M Chou, Lauren H Augustyniak
5 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Gam S Zamil, Mindy M Chou, Lauren H Augustyniak
5 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Gam S Zamil, Mindy M Chou, Lauren H Augustyniak
26 Sep 2024
21 CFR 211.111
Establishment of time limitations
Cited by Adetutu M Gidado, Sean R Marcsisin, Armen H Youssoufian
26 Sep 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Adetutu M Gidado, Sean R Marcsisin, Armen H Youssoufian
Investigators
FDA investigators tied to this site in the record.
Michael W Burd2 insp.
Gam S Zamil1 insp.
Mindy M Chou1 insp.
Lauren H Augustyniak1 insp.
Adetutu M Gidado1 insp.
Sean R Marcsisin1 insp.
Armen H Youssoufian1 insp.
William J Leonard1 insp.
Anastasia M Shields1 insp.
Robert C Horan1 insp.
Charisse K Green1 insp.
James D Bridges1 insp.
Joseph J Vannelli1 insp.
Kimberley A Ricketts1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ONY Biotech, Inc.'s 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat