Purac Biochem BV
⚠️ Moderate Risk
FEI: 3002806633 • Gorinchem, Zuid-Holland • NETHERLANDS
FEI Number
3002806633
Location
Gorinchem, Zuid-Holland
Country
NETHERLANDSAddress
Arkelse Onderweg 46, P.O. Box 21, Gorinchem, Zuid-Holland, Netherlands
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2015 | 65RCS20SODIUM LACTATE (REPLENISHER) | Southwest Import District Office (SWI-DO) | |
| 9/27/2007 | 65RQR15POTASSIUM GLUCONATE (REPLENISHER) | Los Angeles District Office (LOS-DO) | |
| 9/27/2007 | 65RCL15POTASSIUM GLUCONATE (REPLENISHER) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Purac Biochem BV's FDA import refusal history?
Purac Biochem BV (FEI: 3002806633) has 3 FDA import refusal record(s) in our database, spanning from 9/27/2007 to 2/10/2015.
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. Purac Biochem BV's FEI number is 3002806633.
What types of violations has Purac Biochem BV received?
Purac Biochem BV has been cited for 2 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 Purac Biochem BV come from?
All FDA import refusal data for Purac Biochem BV 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.