Degort's Chemical, S.A. de C.V.
⚠️ High Risk
FEI: 3005020284 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3005020284
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Alhambra No. 310, Col. Portales Norte, 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).
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 |
|---|---|---|---|
| 9/27/2022 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 9/22/2022 | 61XAK18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | Division of Southeast Imports (DSEI) | |
| 8/23/2022 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2021 | 62GDY49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 61XDY08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2020 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 62GDA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 60FCA01KAOLIN (ADSORBANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 60SCB23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2018 | 60LCL99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2017 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2009 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Degort's Chemical, S.A. de C.V.'s FDA import refusal history?
Degort's Chemical, S.A. de C.V. (FEI: 3005020284) has 13 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 9/27/2022.
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. Degort's Chemical, S.A. de C.V.'s FEI number is 3005020284.
What types of violations has Degort's Chemical, S.A. de C.V. received?
Degort's Chemical, S.A. de C.V. has been cited for 3 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 Degort's Chemical, S.A. de C.V. come from?
All FDA import refusal data for Degort's Chemical, 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.