Procaps S.A. de C.V.
⚠️ High Risk
FEI: 3013263887 • Soyapango, San Salvador • EL SALVADOR
FEI Number
3013263887
Location
Soyapango, San Salvador
Country
EL SALVADORAddress
Boulevard Of The National Army, Km 5 1/2, , Soyapango, San Salvador, El Salvador
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).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54AFC10MECOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 61NCC69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/13/2025 | 56ACY99PENICILLIN NATURAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2019 | 54ACL01VITAMIN A | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 61JDA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 10/27/2010 | 54ACY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/27/2010 | 54ACY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/8/2009 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/8/2009 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2004 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Procaps S.A. de C.V.'s FDA import refusal history?
Procaps S.A. de C.V. (FEI: 3013263887) has 12 FDA import refusal record(s) in our database, spanning from 10/8/2004 to 12/22/2025.
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. Procaps S.A. de C.V.'s FEI number is 3013263887.
What types of violations has Procaps S.A. de C.V. received?
Procaps S.A. de C.V. has been cited for 2 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 Procaps S.A. de C.V. come from?
All FDA import refusal data for Procaps 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.