CROMA-PHARMA GMBH
⚠️ High Risk
FEI: 3002806738 • Leobendorf, Lower Austria • AUSTRIA
FEI Number
3002806738
Location
Leobendorf, Lower Austria
Country
AUSTRIAAddress
Industriezeile 6, , Leobendorf, Lower Austria, Austria
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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 11/4/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 12/23/2024 | 64DPY99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 4/5/2023 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/9/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 5/14/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 5/7/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Northern Border Imports (DNBI) | |
| 12/13/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CROMA-PHARMA GMBH's FDA import refusal history?
CROMA-PHARMA GMBH (FEI: 3002806738) has 9 FDA import refusal record(s) in our database, spanning from 12/13/2017 to 11/4/2025.
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. CROMA-PHARMA GMBH's FEI number is 3002806738.
What types of violations has CROMA-PHARMA GMBH received?
CROMA-PHARMA GMBH has been cited for 6 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 CROMA-PHARMA GMBH come from?
All FDA import refusal data for CROMA-PHARMA 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.