Donovan Werke
⚠️ High Risk
FEI: 3011068023 • Guatemala • GUATEMALA
FEI Number
3011068023
Location
Guatemala
Country
GUATEMALAAddress
Calzada Roosevelt 22-43, , Guatemala, , Guatemala
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2025 | 65CDY07LEVOCARNITINE (NUTRIENT/TONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 65CDY07LEVOCARNITINE (NUTRIENT/TONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 60LDY17CLONIXIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 56CDY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 61KDY16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 62GCY59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 64LCY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 62GDL49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 62GDL49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 62GCL59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2024 | 61HDY32NITROFURANTOIN (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2024 | 54AGY02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/29/2020 | 65CDA99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2020 | 54AFL02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 54AFL05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 54AFL05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 54AFL05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/13/2014 | 61GCB04NALIDIXIC ACID (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Donovan Werke's FDA import refusal history?
Donovan Werke (FEI: 3011068023) has 22 FDA import refusal record(s) in our database, spanning from 11/13/2014 to 9/11/2025.
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. Donovan Werke's FEI number is 3011068023.
What types of violations has Donovan Werke received?
Donovan Werke 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 Donovan Werke come from?
All FDA import refusal data for Donovan Werke 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.