Serral, S.A. de C.V.
⚠️ High Risk
FEI: 3003084296 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003084296
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Adolfo Prieto No 1009, Col. Del Valle Centro, Benito Juarez, 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2025 | 66SCB49PENTOXIFYLLINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 64UCY06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 60LBA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 65CDA99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 62GDA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 60LDA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 62SDY02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2018 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/15/2018 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/15/2018 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/15/2018 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2018 | 64LCJ03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 61ECB09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2017 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 61CDY99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 61HDA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 61HCA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2017 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 60WCA26PIPERAZINE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 64BCC25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/22/2017 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 61EDP08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2017 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 12/21/2016 | 62ACA03CALCITONIN, SALMON (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2016 | 62TDK07PANTOPRAZOLE SODIUM | New Orleans District Office (NOL-DO) | |
| 10/7/2016 | 62TCB07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/20/2015 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 4/1/2011 | 64GCY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/7/2009 | 54AGK05VITAMIN B12 (CYANOCOBALAMIN) | Cincinnati District Office (CIN-DO) | |
| 9/3/2003 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/2/2003 | 65VCC40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/18/2002 | 63XCA99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2002 | 65VCA40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/22/2002 | 65VCY40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/8/2002 | 65VDC40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/23/2002 | 65VCY40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/2/2002 | 65VDB40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Serral, S.A. de C.V.'s FDA import refusal history?
Serral, S.A. de C.V. (FEI: 3003084296) has 42 FDA import refusal record(s) in our database, spanning from 3/2/2002 to 12/3/2025.
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. Serral, S.A. de C.V.'s FEI number is 3003084296.
What types of violations has Serral, S.A. de C.V. received?
Serral, 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 Serral, S.A. de C.V. come from?
All FDA import refusal data for Serral, 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.