ImportRefusal LogoImportRefusal

Lonza Biologics Plc

⚠️ Moderate Risk

FEI: 1000583959 • Slough, SLG • UNITED KINGDOM

FEI

FEI Number

1000583959

📍

Location

Slough, SLG

🇬🇧
🏢

Address

228 Bath Road, , Slough, SLG, United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
3/2/2017
Latest Refusal
9/22/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.5×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

752×

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).

161×

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.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/2/2017
64OIS99MONOCLONAL ANTIBODIES, N.E.C.
16DIRECTIONS
75UNAPPROVED
Chicago District Office (CHI-DO)
12/7/2016
66YIP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New England District Office (NWE-DO)
9/22/2011
88LDTREAGENT, GENERAL PURPOSE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Lonza Biologics Plc's FDA import refusal history?

Lonza Biologics Plc (FEI: 1000583959) has 3 FDA import refusal record(s) in our database, spanning from 9/22/2011 to 3/2/2017.

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. Lonza Biologics Plc's FEI number is 1000583959.

What types of violations has Lonza Biologics Plc received?

Lonza Biologics Plc has been cited for 3 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 Lonza Biologics Plc come from?

All FDA import refusal data for Lonza Biologics Plc 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.