Compania Internacional de Comercio, S.A.P.I. de C.V.
⚠️ High Risk
FEI: 3002775853 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3002775853
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Monzon (Juarez) No. 184, Col. Cerro De La Estrella, Iztapalapa, 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
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).
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).
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.
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 |
|---|---|---|---|
| 11/4/2024 | 60LDJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2016 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/21/2012 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 11/21/2012 | 56DBJ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 11/21/2012 | 60LBJ99ANALGESIC, N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 11/21/2012 | 61WBJ41ZINC UNDECYLENATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/4/2011 | 56DBJ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/17/2009 | 56DBJ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | Southwest Import District Office (SWI-DO) | |
| 9/10/2003 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 9/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 3/7/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Compania Internacional de Comercio, S.A.P.I. de C.V.'s FDA import refusal history?
Compania Internacional de Comercio, S.A.P.I. de C.V. (FEI: 3002775853) has 11 FDA import refusal record(s) in our database, spanning from 3/7/2002 to 11/4/2024.
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. Compania Internacional de Comercio, S.A.P.I. de C.V.'s FEI number is 3002775853.
What types of violations has Compania Internacional de Comercio, S.A.P.I. de C.V. received?
Compania Internacional de Comercio, S.A.P.I. 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 Compania Internacional de Comercio, S.A.P.I. de C.V. come from?
All FDA import refusal data for Compania Internacional de Comercio, S.A.P.I. 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.