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Ever Pharma Jena GmbH

⚠️ High Risk

FEI: 1000414342 • Jena, Thuringia • GERMANY

FEI

FEI Number

1000414342

📍

Location

Jena, Thuringia

🇩🇪

Country

GERMANY
🏢

Address

Otto-Schott-Str. 15, , Jena, Thuringia, Germany

High Risk

FDA Import Risk Assessment

50.3
LowModerateHighCritical

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

Statistics

23
Total Refusals
3
Unique Violations
11/3/2011
Latest Refusal
5/25/2006
Earliest Refusal

Score Breakdown

Violation Severity
76.8×40%
Refusal Volume
51.1×30%
Recency
0.0×20%
Frequency
42.2×10%
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

2721×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

1183×

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).

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

DateProductViolationsDivision
11/3/2011
60NCK14TESTOSTERONE (ANDROGEN)
118NOT LISTED
Cincinnati District Office (CIN-DO)
12/7/2009
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
27DRUG GMPS
Southwest Import District Office (SWI-DO)
12/7/2009
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
27DRUG GMPS
Southwest Import District Office (SWI-DO)
12/7/2009
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
27DRUG GMPS
Southwest Import District Office (SWI-DO)
11/6/2009
66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
27DRUG GMPS
Southwest Import District Office (SWI-DO)
11/6/2009
66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
27DRUG GMPS
Southwest Import District Office (SWI-DO)
9/18/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
9/1/2009
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
New York District Office (NYK-DO)
5/25/2006
64GIA29LEVONORGESTREL (ESTROGEN)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ever Pharma Jena GmbH's FDA import refusal history?

Ever Pharma Jena GmbH (FEI: 1000414342) has 23 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 11/3/2011.

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. Ever Pharma Jena GmbH's FEI number is 1000414342.

What types of violations has Ever Pharma Jena GmbH received?

Ever Pharma Jena GmbH 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 Ever Pharma Jena GmbH come from?

All FDA import refusal data for Ever Pharma Jena GmbH 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.