Purna Pharmaceuticals NV
⚠️ High Risk
FEI: 3003848224 • Puurs-Sint-Amands, Antwerp • BELGIUM
FEI Number
3003848224
Location
Puurs-Sint-Amands, Antwerp
Country
BELGIUMAddress
Rijksweg 17, , Puurs-Sint-Amands, Antwerp, Belgium
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2024 | 61SBL01COAL TAR (ANTI-ECZEMATIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ECO80TETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ECO80TETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56KCP80SPECTINOMYCIN DIHYDRO-CL PENTAHYDRATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61TCK17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCA50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60QCP67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64LCK37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60CDO09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCO50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64LCK37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60CDO09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56GCO50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56KCP80SPECTINOMYCIN DIHYDRO-CL PENTAHYDRATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 64LCK37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61WCA04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 62FCJ38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 64LCO03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/11/2005 | 61HDR03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 66SDA36VERAPAMIL (VASODILATOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 64LDJ38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 62FDJ38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Purna Pharmaceuticals NV's FDA import refusal history?
Purna Pharmaceuticals NV (FEI: 3003848224) has 32 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 7/1/2024.
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. Purna Pharmaceuticals NV's FEI number is 3003848224.
What types of violations has Purna Pharmaceuticals NV received?
Purna Pharmaceuticals NV 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 Purna Pharmaceuticals NV come from?
All FDA import refusal data for Purna Pharmaceuticals NV 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.