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Kedrion Biopharma Inc. FDA Inspection Record

FEI 3003683714 · Inspections, Form 483s, warning letters and import refusals

Kedrion Biopharma Inc. is an FDA-registered facility (FEI 3003683714) located in Melville, NY, US. Registered operations: MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection: Mar 27, 2024: Voluntary Action Indicated (VAI)
Inspections on record: 6 (6 VAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents: 1 in FDA's reading room
Recalls as the recalling firm: 1, latest Jan 7, 2016

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Mar 27, 2024	Voluntary Action Indicated (VAI)	No citations listed
Jun 25, 2021	Voluntary Action Indicated (VAI)	No citations listed
Aug 29, 2018	Voluntary Action Indicated (VAI)	No citations listed
Sep 29, 2014	Voluntary Action Indicated (VAI)	No citations listed
Aug 2, 2012	Voluntary Action Indicated (VAI)	No citations listed
Jul 21, 2009	Voluntary Action Indicated (VAI)	No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Jan 7, 2016	Class III	B-0244-16	Rh Immune Globulin (Human) Misbranded Rho(D) Immune Globulin (Human) was distributed.

Form 483s and inspection documents

483 on FDA.gov
FDA listing date Dec 6, 2019, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.

Facility details

Company: Kedrion Biopharma Inc.
Location: Melville, NY (US)
Registration Expires: Dec 31, 2026
Operations: MANUFACTURE
Source: decrs