Kedrion Biopharma Inc.
Form 483 issued March 27, 2024 · Melville, New York
- Inspection
- Mar 20 – Mar 27, 2024
- Investigators
- Burnell M. Henry· Travis S. Bradley
- Observations
- 2
- Pages
- 3
- FEI number
- 3003683714
In short: On March 27, 2024, FDA issued a Form 483 with 2 observations to Kedrion Biopharma Inc. in Melville, New York (FEI 3003683714) after an inspection that ran Mar 20 – Mar 27, 2024. The investigators were Burnell M. Henry and Travis S. Bradley. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Established cleaning procedures for critical equipment…
- 02
Deviations from batch production and control…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
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 2 observations on this Form 483, mostly about facilities & equipment 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 Kedrion Biopharma Inc.?
Burnell M. Henry and Travis S. Bradley are named on this Form 483, for the inspection of Mar 20 – Mar 27, 2024. Each investigator has a profile showing what they cite most.
When was Kedrion Biopharma Inc. inspected by FDA?
The inspection ran Mar 20 – Mar 27, 2024, and the Form 483 is dated March 27, 2024.
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.