PASCOE PHARMAZEUTISCHE PRAPARATEGM
⚠️ Moderate Risk
FEI: 3014532908 • Giesen, Hesse • GERMANY
FEI Number
3014532908
Location
Giesen, Hesse
Country
GERMANYAddress
Pascoe Pharmazeutische Praparate Gmbh, Schiffenberger Weg 55, Giesen, Hesse, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is PASCOE PHARMAZEUTISCHE PRAPARATEGM's FDA import refusal history?
PASCOE PHARMAZEUTISCHE PRAPARATEGM (FEI: 3014532908) has 1 FDA import refusal record(s) in our database, spanning from 7/25/2018 to 7/25/2018.
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. PASCOE PHARMAZEUTISCHE PRAPARATEGM's FEI number is 3014532908.
What types of violations has PASCOE PHARMAZEUTISCHE PRAPARATEGM received?
PASCOE PHARMAZEUTISCHE PRAPARATEGM 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 PASCOE PHARMAZEUTISCHE PRAPARATEGM come from?
All FDA import refusal data for PASCOE PHARMAZEUTISCHE PRAPARATEGM 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.