Kedrion Biopharma Inc.
Form 483 issued June 25, 2021 · Melville, New York
- Inspection
- Jun 14 – Jun 25, 2021
- Investigators
- Ann M. Stewart· Burnell M. Henry· David Galler-Veety
- Observations
- 1
- Pages
- 2
- FEI number
- 3003683714
In short: On June 25, 2021, FDA issued a Form 483 with 1 observation to Kedrion Biopharma Inc. in Melville, New York (FEI 3003683714) after an inspection that ran Jun 14 – Jun 25, 2021. The investigators were Ann M. Stewart, Burnell M. Henry, David Galler-Veety and Susan M. Jackson. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
During the walk through of the facility on June 14, 2021 the…
This inspection in context
Ann M. Stewart
1 document · 2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmKedrion Biopharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kedrion Biopharma Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Kedrion Biopharma Inc.?
Ann M. Stewart, Burnell M. Henry, David Galler-Veety and Susan M. Jackson are named on this Form 483, for the inspection of Jun 14 – Jun 25, 2021. Each investigator has a profile showing what they cite most.
When was Kedrion Biopharma Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 25, 2021, and the Form 483 is dated June 25, 2021.
How do I get the full Form 483 for Kedrion Biopharma Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.