Xellia Pharmaceuticals ApS

⚠️ Moderate Risk

FEI: 3002806860 • Copenhagen S • DENMARK

FEI

FEI Number

3002806860

📍

Location

Copenhagen S

🇩🇰

Country

DENMARK

🏢

Address

Dalslandsgade 11, , Copenhagen S, , Denmark

Moderate Risk

FDA Import Risk Assessment

42.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/27/2018

Latest Refusal

7/29/2002

Earliest Refusal

Score Breakdown

Violation Severity

76.4×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

6.3×10%

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

757×

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).

1182×

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).

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.

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

Refusal History

Date	Product	Violations	Division
7/27/2018	56KCS85VANCOMYCIN HYDROCHLORIDE	75UNAPPROVED	Division of Northeast Imports (DNEI)
8/4/2016	56FCS21COLISTIN SULFATE (PEPTIDES)	118NOT LISTED	Division of Northern Border Imports (DNBI)
8/1/2014	67A08BACITRACIN ZINC CATEGORY I, TYPE A MEDICATED ARTICLE	75UNAPPROVED	Florida District Office (FLA-DO)
2/19/2014	56FBK30POLYMYXIN B SULFATE (PEPTIDES)	75UNAPPROVED	Division of Northeast Imports (DNEI)
10/18/2010	56KCS85VANCOMYCIN HYDROCHLORIDE	118NOT LISTED 75UNAPPROVED	Chicago District Office (CHI-DO)
2/25/2009	56KYY85VANCOMYCIN HYDROCHLORIDE	75UNAPPROVED	Chicago District Office (CHI-DO)
2/25/2009	56KYY85VANCOMYCIN HYDROCHLORIDE	75UNAPPROVED	Chicago District Office (CHI-DO)
1/15/2009	56KYY85VANCOMYCIN HYDROCHLORIDE	75UNAPPROVED	Chicago District Office (CHI-DO)
3/11/2004	56FCS21COLISTIN SULFATE (PEPTIDES)	2880RXCOMPOUND	Chicago District Office (CHI-DO)
7/29/2002	56FCS21COLISTIN SULFATE (PEPTIDES)	16DIRECTIONS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Xellia Pharmaceuticals ApS's FDA import refusal history?

Xellia Pharmaceuticals ApS (FEI: 3002806860) has 10 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 7/27/2018.

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. Xellia Pharmaceuticals ApS's FEI number is 3002806860.

What types of violations has Xellia Pharmaceuticals ApS received?

Xellia Pharmaceuticals ApS 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 Xellia Pharmaceuticals ApS come from?

All FDA import refusal data for Xellia Pharmaceuticals ApS 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.