Laboratorios Sophia, S.A. De C.V.
⚠️ High Risk
FEI: 1000310459 • Zapopan, Jalisco • MEXICO
FEI Number
1000310459
Location
Zapopan, Jalisco
Country
MEXICOAddress
Av. Paseo Del Norte No. 5255, Guadalajara Technology Park, Zapopan, Jalisco, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
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 | 64WCL99IRRIGATION SOLUTION N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2024 | 64LDY51PREDNISOLONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2023 | 64DAK99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 11/28/2023 | 61XCK99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 60NDK99ANDROGEN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 60XDL23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2019 | 65KCY08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2017 | 60CCY54BRIMONIDINE TARTRATE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2016 | 61MCB11MAGNESIUM SULFATE (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/31/2011 | 65FBK06WATER, PURIFIED (EYEWASH) | Southwest Import District Office (SWI-DO) | |
| 3/6/2006 | 63K99CHEMOTIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/4/2001 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/4/2001 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios Sophia, S.A. De C.V.'s FDA import refusal history?
Laboratorios Sophia, S.A. De C.V. (FEI: 1000310459) has 14 FDA import refusal record(s) in our database, spanning from 12/4/2001 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. Laboratorios Sophia, S.A. De C.V.'s FEI number is 1000310459.
What types of violations has Laboratorios Sophia, S.A. De C.V. received?
Laboratorios Sophia, 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 Laboratorios Sophia, S.A. De C.V. come from?
All FDA import refusal data for Laboratorios Sophia, 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.