Novag Infancia S.A. de C.V.
⚠️ High Risk
FEI: 3003701036 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003701036
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Calzada De Tlalpan No. 3417, Condominio Santa Ursula Coapa, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, Mexico
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 |
|---|---|---|---|
| 3/28/2023 | 56DDB40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 62HCA03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 56GCO99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 56GCA99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2016 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2016 | 62GAB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/1/2016 | 60LCY17CLONIXIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/13/2015 | 60SCA23METOCLOPRAMIDE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 1/13/2015 | 64TAA04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | Division of Southeast Imports (DSEI) | |
| 1/6/2015 | 61PAB11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2012 | 61JCA13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2004 | 54FDA22SASSAFRAS (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novag Infancia S.A. de C.V.'s FDA import refusal history?
Novag Infancia S.A. de C.V. (FEI: 3003701036) has 15 FDA import refusal record(s) in our database, spanning from 8/24/2004 to 3/28/2023.
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. Novag Infancia S.A. de C.V.'s FEI number is 3003701036.
What types of violations has Novag Infancia S.A. de C.V. received?
Novag Infancia S.A. de C.V. 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 Novag Infancia S.A. de C.V. come from?
All FDA import refusal data for Novag Infancia 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.