Teresita Santos Calderon
⚠️ Moderate Risk
FEI: 3007138536 • Ixtapalucaixtapaluca • MEXICO
FEI Number
3007138536
Location
Ixtapalucaixtapaluca
Country
MEXICOAddress
Ret 48 Mz 41 Lt 69a Col Cuatro Vientos, , Ixtapalucaixtapaluca, , 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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/16/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/16/2008 | 56DIY06AMIKACIN SULFATE (AMINOGLYCOSIDES) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Teresita Santos Calderon's FDA import refusal history?
Teresita Santos Calderon (FEI: 3007138536) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2008 to 10/16/2008.
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. Teresita Santos Calderon's FEI number is 3007138536.
What types of violations has Teresita Santos Calderon received?
Teresita Santos Calderon has been cited for 3 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 Teresita Santos Calderon come from?
All FDA import refusal data for Teresita Santos Calderon 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.