Bioline

⚠️ Moderate Risk

FEI: 3001436238 • London • UNITED KINGDOM

FEI

FEI Number

3001436238

📍

Location

London

🇬🇧

Country

UNITED KINGDOM

🏢

Address

14 The Elms, , London, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

48.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/18/2016

Latest Refusal

11/12/2014

Earliest Refusal

Score Breakdown

Violation Severity

57.1×40%

Refusal Volume

52.4×30%

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

11824×

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).

328024×

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.

50824×

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
3/18/2016	54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/12/2014	75JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bioline's FDA import refusal history?

Bioline (FEI: 3001436238) has 25 FDA import refusal record(s) in our database, spanning from 11/12/2014 to 3/18/2016.

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. Bioline's FEI number is 3001436238.

What types of violations has Bioline received?

Bioline has been cited for 4 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 Bioline come from?

All FDA import refusal data for Bioline 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.