Abbott Medical

FDA establishment 2017865, Sylmar, California, United States. Part of Abbott Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 13
Official action indicated: 2
Last inspection ended: Jun 28, 2023
Warning letters: 1

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

12019

02021

12023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

13 inspections, newest first

Ended	Product and area	Citations	Classification
Jun 28, 2023	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	3 cited references 21 CFR 806.10(a)(1). Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 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.	Voluntary Action Indicated (VAI)
Jan 17, 2020	Devices · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Aug 2, 2019	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Devices · Project Evaluation: Devices	None posted	Voluntary Action Indicated (VAI)
Feb 17, 2017	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	6 cited references 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements. 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete. 21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established. 21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled. 21 CFR 806.10(a)(1). Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.	Official Action Indicated (OAI)
Mar 24, 2016	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Nov 24, 2015	Devices · Compliance: DevicesDrugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Apr 9, 2015	Devices · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 11, 2014	Devices · Compliance: Devices	1 cited reference 21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Procedures for design verification have not been adequately established.	Voluntary Action Indicated (VAI)
Aug 1, 2013	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	None posted	Voluntary Action Indicated (VAI)
Oct 17, 2012	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	Official Action Indicated (OAI)
May 4, 2012	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	None posted	No Action Indicated (NAI)
Sep 20, 2011	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jul 8, 2009	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	8 cited references 21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury. 21 CFR 820.250(b). Reviewed for adequacy Sampling methods have not been reviewed for adequacy for their intended use. 21 CFR 803.50(b)(1). Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete. 21 CFR 820.30(e). Design reviews performed following schedule Design reviews were not performed at appropriate times, following the review schedule. 21 CFR 820.100(a). Lack of or inadequate procedures The procedures for implementing corrective and preventive actions were not defined. 21 CFR 820.30(f). Design verification - unresolved discrepancies Unresolved discrepancies were noted at the completion of the design verification. 21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures were not established for the validation or verification, review, and approval of design changes before their implementation.	Voluntary Action Indicated (VAI)

Warning Letters

Letters naming this establishment; each opens the letter

CAPA, Design controls, 510(k) requiredApr 12, 2017

Identifiers

FEI number: 2017865
FDA firm profile: Data Dashboard
Company: Abbott Medical

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