Black Banana Internet

⚠️ Moderate Risk

FEI: 3011271227 • Liskeardliskeard • UNITED KINGDOM

FEI

FEI Number

3011271227

📍

Location

Liskeardliskeard

🇬🇧

Country

UNITED KINGDOM

🏢

Address

Prince Albert House Liskeard Business, , Liskeardliskeard, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

49.9

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/10/2018

Latest Refusal

12/6/2018

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

53.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

11826×

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).

328026×

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.

248025×

RXPERSONAL

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

50825×

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.

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
12/10/2018	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/10/2018	86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/10/2018	86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/10/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 237NO PMA 2480RXPERSONAL 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/7/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LRXCASE, CONTACT LENS	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
12/6/2018	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2018	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	118NOT LISTED 2480RXPERSONAL 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Black Banana Internet's FDA import refusal history?

Black Banana Internet (FEI: 3011271227) has 26 FDA import refusal record(s) in our database, spanning from 12/6/2018 to 12/10/2018.

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. Black Banana Internet's FEI number is 3011271227.

What types of violations has Black Banana Internet received?

Black Banana Internet has been cited for 5 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 Black Banana Internet come from?

All FDA import refusal data for Black Banana Internet 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.