Allergan Sales, LLC

FDA establishment 2011068, Irvine, California, United States. Part of Allergan Sales's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.

Inspections: 13
Official action indicated: 0
Last inspection ended: Sep 19, 2025
Warning letters: 1
Recalls since 2016: 6
Import refusals since 2024: 3

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

12019

02021

12023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

13 inspections, newest first

Ended	Product and area	Citations	Classification
Sep 19, 2025	Devices · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Jul 28, 2023	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Jan 22, 2019	Devices · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Oct 19, 2016	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jan 15, 2016	Drugs · Bioresearch Monitoring	3 cited references 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed . 21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.	Voluntary Action Indicated (VAI)
Dec 7, 2015	Devices · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 15, 2014	Drugs · Bioresearch Monitoring	None posted	Voluntary Action Indicated (VAI)
Dec 23, 2013	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 2, 2013	Drugs · Drug Quality AssuranceDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jul 3, 2012	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Aug 30, 2011	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Sep 20, 2010	Drugs · Drug Quality AssuranceDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jul 9, 2010	Drugs · Bioresearch Monitoring	3 cited references 21 CFR 314.80(c)(2). Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. 21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. 21 CFR 314.81(b)(2). Timely submission An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.	Voluntary Action Indicated (VAI)

Warning Letters

Letters naming this establishment; each opens the letter

510(k) requiredMay 14, 2020

Recalls

6 drug, device and biologic recalls since 2016, newest first; 1 Class I

Recalled product	Class	Classified
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,Device · Z-1694-2024	Class II	Mar 14, 2024
REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileDevice · Z-0948-2021	Class II	Dec 29, 2020
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by…Drug · D-1409-2020 · 2 products	Class III	Jul 6, 2020
Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68…Device · Z-0699-2020 · 4 products	Class III	Nov 6, 2019
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers…Device · Z-0598-2020	Class II	Oct 30, 2019
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style…Device · Z-2451-2019 · 15 products	Class I	Jul 24, 2019

Import Refusals

3 refused shipment lines since 2024, grouped by product and charges

Product	Charges	Latest
IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	Maker not registered with FDANO PMADrug or device not listed with FDA	Feb 19, 2026
MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBY99	Maker not registered with FDADrug or device not listed with FDA	Dec 2, 2024
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.Drugs · 66YDY99	Unapproved new drug	Jan 16, 2024

Identifiers

FEI number: 2011068
FDA firm profile: Data Dashboard
Company: Allergan Sales

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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports