Kedrion Biopharma Inc.
FDA inspection history in Melville, New York, 2021 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Melville, New York.
- 2024One Form 483, at Melville, New York.
- 2024The longest 483 on file: 2 observations over 3 pages at Melville, New York.
Cited most
Across all Kedrion Biopharma observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
The complete Kedrion Biopharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Melville, New York
Two Form 483s · 2021 to 2024 · 3 observations
Latest: Form 483, Mar 27, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-27 | 483 Form 483 | Melville, New York | 2 | $99 |
| 2021-06-25 | 483 Form 483 | Melville, New York | 1 | $99 |
Investigators on these documents
Burnell M. Henry (2)Ann M. Stewart (1)David Galler-Veety (1)Susan M. Jackson (1)Travis S. Bradley (1)
FEI number 3003683714 · most recent document Mar 27, 2024
About Kedrion Biopharma Inc.
How many FDA Form 483s has Kedrion Biopharma Inc. received?
FDA Intel has 2 Form 483s on file for Kedrion Biopharma Inc.; the most recent is dated Mar 27, 2024.
When was Kedrion Biopharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for Kedrion Biopharma Inc. is a Form 483 dated Mar 27, 2024, for the site in Melville, New York.
What did FDA cite at Kedrion Biopharma Inc.?
The regulations cited most in the observations on file for Kedrion Biopharma Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.