Rommelag CDMO GmbH
⚠️ Moderate Risk
FEI: 3002808845 • Sulzbach-Laufen, Baden-Wurttemberg • GERMANY
FEI Number
3002808845
Location
Sulzbach-Laufen, Baden-Wurttemberg
Country
GERMANYAddress
Bahnhof Str. 18, , Sulzbach-Laufen, Baden-Wurttemberg, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2017 | 65FBK06WATER, PURIFIED (EYEWASH) | Baltimore District Office (BLT-DO) | |
| 6/29/2016 | 65FBK06WATER, PURIFIED (EYEWASH) | Baltimore District Office (BLT-DO) | |
| 6/29/2016 | 65FBK06WATER, PURIFIED (EYEWASH) | Baltimore District Office (BLT-DO) | |
| 7/30/2012 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/4/2010 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/4/2010 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/6/2004 | 65FAK02WATER, PURIFIED, U.S.P. (PHARMACEUTIC AID) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rommelag CDMO GmbH's FDA import refusal history?
Rommelag CDMO GmbH (FEI: 3002808845) has 7 FDA import refusal record(s) in our database, spanning from 10/6/2004 to 1/4/2017.
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. Rommelag CDMO GmbH's FEI number is 3002808845.
What types of violations has Rommelag CDMO GmbH received?
Rommelag CDMO GmbH 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 Rommelag CDMO GmbH come from?
All FDA import refusal data for Rommelag CDMO 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.