Pharmacia & Upjohn S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003740568 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003740568
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Calzada De Tlalpan # 2962, Col. Espartaco, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, Mexico
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).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2006 | 54BRP12SODIUM (MINERAL) | New Orleans District Office (NOL-DO) | |
| 9/16/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/16/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2002 | 61TBK06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/13/2002 | 61TBA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/10/2002 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Pharmacia & Upjohn S.A. de C.V.'s FDA import refusal history?
Pharmacia & Upjohn S.A. de C.V. (FEI: 3003740568) has 6 FDA import refusal record(s) in our database, spanning from 7/10/2002 to 6/7/2006.
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. Pharmacia & Upjohn S.A. de C.V.'s FEI number is 3003740568.
What types of violations has Pharmacia & Upjohn S.A. de C.V. received?
Pharmacia & Upjohn S.A. de C.V. 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 Pharmacia & Upjohn S.A. de C.V. come from?
All FDA import refusal data for Pharmacia & Upjohn S.A. de C.V. 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.