UQUIFA Mexico, S.A. de C.V.
⚠️ Moderate Risk
FEI: 1000260514 • Jiutepec, Morelos • MEXICO
FEI Number
1000260514
Location
Jiutepec, Morelos
Country
MEXICOAddress
Calle 37 Este No 126 Apdo 430, Jiutepec, Jiutepec, Morelos, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2017 | 61FDS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 2/28/2017 | 61PDS55METFORMIN HCL (ANTI-DIABETIC) | New Orleans District Office (NOL-DO) | |
| 5/1/2014 | 61PIY26METFORMIN (ANTI-DIABETIC) | New Orleans District Office (NOL-DO) | |
| 4/25/2014 | 61FAZ54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 223FALSE | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 61FIY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2001 | 60SCS25RANITIDINE HYDROCHLORIDE (ANTACID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is UQUIFA Mexico, S.A. de C.V.'s FDA import refusal history?
UQUIFA Mexico, S.A. de C.V. (FEI: 1000260514) has 7 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 2/28/2017.
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. UQUIFA Mexico, S.A. de C.V.'s FEI number is 1000260514.
What types of violations has UQUIFA Mexico, S.A. de C.V. received?
UQUIFA Mexico, S.A. de C.V. has been cited for 6 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 UQUIFA Mexico, S.A. de C.V. come from?
All FDA import refusal data for UQUIFA Mexico, 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.