ONY Biotech Inc.
FDA inspection history in Amherst, New York, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Amherst, New York.
Cited most
Across all ONY Biotech observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- FDCA 582(b)(4)2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete ONY Biotech file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Amherst, New York
One Form 483 · 2024 · 11 observations
Latest: Form 483, Sep 26, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-26 | 483 Form 483 | Amherst, New York | 11 | $99 |
Investigators on these documents
FEI number 1319086 · most recent document Sep 26, 2024
About ONY Biotech Inc.
How many FDA Form 483s has ONY Biotech Inc. received?
FDA Intel has 1 Form 483 on file for ONY Biotech Inc.; the most recent is dated Sep 26, 2024.
When was ONY Biotech Inc. last inspected by FDA?
The most recent FDA inspection document on file for ONY Biotech Inc. is a Form 483 dated Sep 26, 2024, for the site in Amherst, New York.
What did FDA cite at ONY Biotech Inc.?
The regulations cited most in the observations on file for ONY Biotech Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; FDCA 582(b)(4), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time.