Immucor, Inc.

FDA establishment 1034569, Peachtree Corners, Georgia, United States. Part of Immucor's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 7
Official action indicated: 0
Last inspection ended: Feb 20, 2025
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

12021

02023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first

Ended	Product and area	Citations	Classification
Feb 20, 2025	Biologics · Blood and Blood Products	7 cited references 21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled. 21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established. 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed. 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate and is incomplete. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements. 21 CFR 806.20(b)(4). Justification for not reporting A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.	Voluntary Action Indicated (VAI)
Jul 30, 2021	Biologics · Blood and Blood Products	None posted	Voluntary Action Indicated (VAI)
Nov 17, 2017	Biologics · Blood and Blood ProductsDevices · Postmarket Assurance: Devices	None posted	Voluntary Action Indicated (VAI)
Nov 20, 2015	Devices · Postmarket Assurance: DevicesBiologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Dec 10, 2013	Biologics · Blood and Blood Products	None posted	Voluntary Action Indicated (VAI)
Jul 24, 2012	Biologics · Blood and Blood Products	None posted	Voluntary Action Indicated (VAI)
Jul 1, 2010	Biologics · Blood and Blood Products	None posted	Voluntary Action Indicated (VAI)

Identifiers

FEI number: 1034569
FDA firm profile: Data Dashboard
Company: Immucor

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters