Hexal AG
⚠️ High Risk
FEI: 3003462123 • Holzkirchen, Bavaria • GERMANY
FEI Number
3003462123
Location
Holzkirchen, Bavaria
Country
GERMANYAddress
Industriestr. 25, , Holzkirchen, 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).
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).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2024 | 61UCY99ANTI-ESTROGEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2024 | 64BCY50TORSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2021 | 61MCA38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 62GAJ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2019 | 64RCY21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2018 | 61NCB73MIRTAZAPINE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 7/6/2016 | 54BBY01CALCIUM (MINERAL) | Chicago District Office (CHI-DO) | |
| 1/14/2016 | 62GAB86ALLOPURINOL SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/26/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 2/9/2010 | 60RDB16PHENTERMINE (ANOREXIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/3/2008 | 62CCP65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/9/2001 | 61FCY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hexal AG's FDA import refusal history?
Hexal AG (FEI: 3003462123) has 12 FDA import refusal record(s) in our database, spanning from 11/9/2001 to 6/13/2024.
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. Hexal AG's FEI number is 3003462123.
What types of violations has Hexal AG received?
Hexal AG 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 Hexal AG come from?
All FDA import refusal data for Hexal AG 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.