PolyPeptide SA
⚠️ Moderate Risk
FEI: 3002808410 • Braine-L'Alleud, Brabant wallon • BELGIUM
FEI Number
3002808410
Location
Braine-L'Alleud, Brabant wallon
Country
BELGIUMAddress
Chaussee De Tubize 297, , Braine-L'Alleud, Brabant wallon, Belgium
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
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).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/28/2007 | 66MDB83HYDROXYZINE HCL (TRANQUILIZER) | San Francisco District Office (SAN-DO) | |
| 1/23/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is PolyPeptide SA's FDA import refusal history?
PolyPeptide SA (FEI: 3002808410) has 3 FDA import refusal record(s) in our database, spanning from 1/23/2002 to 9/5/2007.
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. PolyPeptide SA's FEI number is 3002808410.
What types of violations has PolyPeptide SA received?
PolyPeptide SA has been cited for 3 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 PolyPeptide SA come from?
All FDA import refusal data for PolyPeptide SA 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.