Laboratorios Quimica Son's, S.A. de C.V
⚠️ High Risk
FEI: 3012780097 • San Andres Cholula, Puebla • MEXICO
FEI Number
3012780097
Location
San Andres Cholula, Puebla
Country
MEXICOAddress
Boulevard de los Reyes No. 6217,Junta Auxiliar de San Bernardino, , San Andres Cholula, Puebla, 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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 65CDY99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 62GDY49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 60LAY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 61TCY11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 64EDY02PANCREATIN (ENZYME) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2024 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2024 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2024 | 62VCF01AMANTADINE HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 64LCY19DEXAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 10/24/2023 | 64LCK06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2023 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2023 | 64ECA02PANCREATIN (ENZYME) | Division of Southeast Imports (DSEI) | |
| 6/16/2023 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 56DDY49NEOMYCIN, N.E.C. (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 60QDY67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2022 | 56KCK10CHLORAMPHENICOL | Division of Southeast Imports (DSEI) | |
| 9/22/2022 | 56JDM20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | Division of Southeast Imports (DSEI) | |
| 7/5/2022 | 62GBA59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2021 | 61WCY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61TDY11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61TDY11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2019 | 61CCL99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2018 | 64LCY02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2017 | 60LAA05ASPIRIN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 12/21/2016 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 61GDA04NALIDIXIC ACID (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Quimica Son's, S.A. de C.V's FDA import refusal history?
Laboratorios Quimica Son's, S.A. de C.V (FEI: 3012780097) has 30 FDA import refusal record(s) in our database, spanning from 11/28/2016 to 7/3/2025.
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 Quimica Son's, S.A. de C.V's FEI number is 3012780097.
What types of violations has Laboratorios Quimica Son's, S.A. de C.V received?
Laboratorios Quimica Son's, 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 Quimica Son's, S.A. de C.V come from?
All FDA import refusal data for Laboratorios Quimica Son's, 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.