Pfizer Laboratoriesfse Comptabilite Fourniss
⚠️ Moderate Risk
FEI: 3003516629 • Cedex Paris • FRANCE
FEI Number
3003516629
Location
Cedex Paris
Country
FRANCEAddress
23-25 Ave Du Dr Lannelounge, , Cedex Paris, , France
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2012 | 56JCY20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/13/2011 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2010 | 61XIK18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/27/2008 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/27/2006 | 63HCK15MINERAL OIL (CATHARTIC) | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 9/13/2005 | 61XBC37TRIPROLIDINE HCL (ANTI-HISTAMINIC) | New Orleans District Office (NOL-DO) | |
| 9/13/2005 | 66VBM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2004 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pfizer Laboratoriesfse Comptabilite Fourniss's FDA import refusal history?
Pfizer Laboratoriesfse Comptabilite Fourniss (FEI: 3003516629) has 8 FDA import refusal record(s) in our database, spanning from 9/22/2004 to 4/12/2012.
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. Pfizer Laboratoriesfse Comptabilite Fourniss's FEI number is 3003516629.
What types of violations has Pfizer Laboratoriesfse Comptabilite Fourniss received?
Pfizer Laboratoriesfse Comptabilite Fourniss 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 Pfizer Laboratoriesfse Comptabilite Fourniss come from?
All FDA import refusal data for Pfizer Laboratoriesfse Comptabilite Fourniss 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.