SpineCraft, LLC.

FDA establishment 3004717358, Westmont, Illinois, United States. Part of SpineCraft's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 5
Official action indicated: 0
Last inspection ended: Mar 22, 2024
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

22019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

5 inspections, newest first

Ended	Product and area	Citations	Classification
Mar 22, 2024	Devices · Compliance: Devices	2 cited references 21 CFR 803.18(b)(1)(i). Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable. 21 CFR 820.198(a). Complaints Complaint files are not adequately maintained.	Voluntary Action Indicated (VAI)
Dec 13, 2018	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	None posted	No Action Indicated (NAI)
Nov 14, 2018	Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)
Aug 18, 2016	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Biologics · Human Cellular, Tissue, and Gene Therapies	None posted	No Action Indicated (NAI)
Apr 12, 2012	Biologics · Human Cellular, Tissue, and Gene TherapiesDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices	None posted	No Action Indicated (NAI)

Identifiers

FEI number: 3004717358
FDA firm profile: Data Dashboard
Company: SpineCraft

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