Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung
⚠️ Moderate Risk
FEI: 3002923756 • Bexbach, Saarland • GERMANY
FEI Number
3002923756
Location
Bexbach, Saarland
Country
GERMANYAddress
Am Kraftwerk 6, , Bexbach, Saarland, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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.
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 |
|---|---|---|---|
| 4/1/2016 | 66JSS01LEVOTHYROXINE SODIUM (THYROID HORMONE) | Chicago District Office (CHI-DO) | |
| 4/8/2013 | 66JCS02LIOTHYRONINE SODIUM (THYROID HORMONE) | 72NEW VET DR | Atlanta District Office (ATL-DO) |
| 3/27/2013 | 66JLR01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung's FDA import refusal history?
Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung (FEI: 3002923756) has 3 FDA import refusal record(s) in our database, spanning from 3/27/2013 to 4/1/2016.
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. Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung's FEI number is 3002923756.
What types of violations has Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung received?
Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung 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 Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung come from?
All FDA import refusal data for Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschr��nkter Haftung 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.