Neurotron, Inc.

FDA establishment 1121806, Aurora, Colorado, United States. Part of Neurotron, Inc.'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: Aug 21, 2026
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

21 CFR 803.17: Lack of Written MDR Procedures2
ISO 13485:2016 Clause 7.5.8: Product status identification was not maintained1
ISO 13485:2016 Clause 7.4.3: Purchased product verification activities not established or implemented1
ISO 13485:2016 Clause 7.5.4: Servicing procedures and reference materials and measurements not documented1
ISO 13485:2016 Clause 7.4.1: Procedures for purchasing process not documented1
ISO 13485:2016 Clause 8.5.2: Corrective action procedures not documented1
21 CFR 820.200(a): Servicing - Lack of or inadequate procedures1
21 CFR 820.72(a): Calibration, Inspection, etc. Procedures Lack of or Inadequ1

Inspections

7 inspections, newest first

Ended	Product and area	Citations	Classification
Aug 21, 2026	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	6 cited references ISO 13485:2016 Clause 7.5.8. Product status identification was not maintained Identification of product status was not maintained throughout production of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used, or installed. ISO 13485:2016 Clause 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not adequately established and implemented. ISO 13485:2016 Clause 7.5.4. Servicing procedures and reference materials and measurements not documented The servicing procedures for performing servicing activities and verifying that product requirements are met were not adequately documented. ISO 13485:2016 Clause 7.4.1. Procedures for purchasing process not documented Procedures to ensure that purchased product conforms to specified purchasing information have not been adequately documented. 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed. ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for planning and documenting action needed and implementing such action and reviewing the effectiveness of corrective action taken have not been adequately documented.	Voluntary Action Indicated (VAI)
Apr 10, 2017	Devices · Compliance: Devices	2 cited references 21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities have not been adequately established. 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.	Voluntary Action Indicated (VAI)
Apr 10, 2017	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	4 cited references 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established. 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established. 21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.	Voluntary Action Indicated (VAI)
Sep 18, 2012	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Sep 12, 2012	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Sep 27, 2010	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Dec 17, 2008	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)

Identifiers

FEI number: 1121806
FDA firm profile: Data Dashboard
Company: Neurotron, Inc.

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