Bausch & Lomb Ireland Limited

⚠️ High Risk

FEI: 3002806454 • Waterford, Co. WATERFORD • IRELAND

FEI

FEI Number

3002806454

📍

Location

Waterford, Co. WATERFORD

🇮🇪

Country

IRELAND

🏢

Address

Unit 424/425, Western Extension Industrial Estate, Cork Road, Waterford, Co. WATERFORD, Ireland

High Risk

FDA Import Risk Assessment

55.9

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

4/24/2024

Latest Refusal

11/20/2003

Earliest Refusal

Score Breakdown

Violation Severity

62.9×40%

Refusal Volume

54.2×30%

Recency

65.7×20%

Frequency

13.7×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1619×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1188×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32807×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

842×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

24802×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

Date	Product	Violations	Division
4/24/2024	86LPLLENSES, SOFT CONTACT, DAILY WEAR	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/25/2019	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG	Division of Southeast Imports (DSEI)
8/2/2018	86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/7/2017	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/29/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS 223FALSE	New York District Office (NYK-DO)
5/17/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	3280FRNMFGREG	Florida District Office (FLA-DO)
1/5/2016	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS 84RX DEVICE	Florida District Office (FLA-DO)
10/16/2015	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 16DIRECTIONS	Florida District Office (FLA-DO)
9/10/2015	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 16DIRECTIONS 508NO 510(K)	Florida District Office (FLA-DO)
9/10/2015	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS 3280FRNMFGREG	Florida District Office (FLA-DO)
9/10/2015	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS 3280FRNMFGREG	Florida District Office (FLA-DO)
8/17/2015	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED	New York District Office (NYK-DO)
7/13/2015	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 237NO PMA 2480RXPERSONAL	Seattle District Office (SEA-DO)
8/22/2014	86LPLLENSES, SOFT CONTACT, DAILY WEAR	3280FRNMFGREG	Cincinnati District Office (CIN-DO)
8/22/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/22/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/22/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/21/2013	86LPLLENSES, SOFT CONTACT, DAILY WEAR	16DIRECTIONS	New Orleans District Office (NOL-DO)
8/5/2010	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED	New York District Office (NYK-DO)
11/20/2003	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	84RX DEVICE	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bausch & Lomb Ireland Limited's FDA import refusal history?

Bausch & Lomb Ireland Limited (FEI: 3002806454) has 28 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 4/24/2024.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bausch & Lomb Ireland Limited's FEI number is 3002806454.

What types of violations has Bausch & Lomb Ireland Limited received?

Bausch & Lomb Ireland Limited has been cited for 8 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Bausch & Lomb Ireland Limited come from?

All FDA import refusal data for Bausch & Lomb Ireland Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.