BOEHRINGER INGELHEIM PROMECO S.A. de C.V.
⚠️ High Risk
FEI: 1000183111 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
1000183111
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Del Maiz No. 49, Col. Xaltocan, Xochimilco, 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).
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)).
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 |
|---|---|---|---|
| 3/21/2025 | 61PDA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2024 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 62CCY10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2022 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 62YBA05BALSALAZIDE DISODIUM (ANTI-INFLAMMATORY, PART II) | Division of Southeast Imports (DSEI) | |
| 9/28/2022 | 61LCA41DABIGATRAN ETEXILATE MESYLATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/26/2019 | 61TCY29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 62ODC09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/8/2016 | 61KDA25HYOSCYAMINE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2016 | 61WAJ52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Florida District Office (FLA-DO) | |
| 4/5/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/15/2016 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2012 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 66VCF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/11/2010 | 61HCB32NITROFURANTOIN (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2008 | 64HAK01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/21/2008 | 60LCS21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2008 | 64GDK07ESTRADIOL (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 6/4/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/1/2006 | 64HDB01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62YBC07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/1/2003 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is BOEHRINGER INGELHEIM PROMECO S.A. de C.V.'s FDA import refusal history?
BOEHRINGER INGELHEIM PROMECO S.A. de C.V. (FEI: 1000183111) has 24 FDA import refusal record(s) in our database, spanning from 12/1/2003 to 3/21/2025.
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. BOEHRINGER INGELHEIM PROMECO S.A. de C.V.'s FEI number is 1000183111.
What types of violations has BOEHRINGER INGELHEIM PROMECO S.A. de C.V. received?
BOEHRINGER INGELHEIM PROMECO S.A. de C.V. has been cited for 5 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 BOEHRINGER INGELHEIM PROMECO S.A. de C.V. come from?
All FDA import refusal data for BOEHRINGER INGELHEIM PROMECO 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.