Chevita Gmbh
⚠️ High Risk
FEI: 1000562924 • Pfaffenhofen A.D.Ilm, Bavaria • GERMANY
FEI Number
1000562924
Location
Pfaffenhofen A.D.Ilm, Bavaria
Country
GERMANYAddress
Raiffeisenstrabe 2, Postfach 1641, Pfaffenhofen A.D.Ilm, Bavaria, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 6/10/2008 | 67C61TYLOSIN COMBO CATEGORY I & II, TYPE A MEDICATED ARTICLE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 67C25FURAZOLIDONE COMBO CATEGORY I & II, TYPE A MEDICATED ARTICLE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 67C25FURAZOLIDONE COMBO CATEGORY I & II, TYPE A MEDICATED ARTICLE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 56EKR10CHLORTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 56EKE10CHLORTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 66YPK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 67B03AMPROLIUM CATEGORY II, TYPE A MEDICATED ARTICLE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 68BCE20ANTI-INFECTIVE USED MORE THAN 1 SPECIES | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 68BCE20ANTI-INFECTIVE USED MORE THAN 1 SPECIES | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 68ACE20ANTHELMINTIC USED MORE THAN 1 SPECIES | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 88NYAANTIBODY, HELPER T CELL, IMMUNOHISTOCHEMISTRY | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 56BJZ07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 56BJZ07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Chevita Gmbh's FDA import refusal history?
Chevita Gmbh (FEI: 1000562924) has 13 FDA import refusal record(s) in our database, spanning from 6/10/2008 to 6/10/2008.
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. Chevita Gmbh's FEI number is 1000562924.
What types of violations has Chevita Gmbh received?
Chevita Gmbh has been cited for 1 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 Chevita Gmbh come from?
All FDA import refusal data for Chevita 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.