Genesis Partnership Company SA
⚠️ High Risk
FEI: 3016785739 • Villa Nueva, Guatemala • GUATEMALA
FEI Number
3016785739
Location
Villa Nueva, Guatemala
Country
GUATEMALAAddress
Km 19.5 Carretera Al Pacifico, Bodega 28, , Villa Nueva, 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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
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).
REDUCED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 64AAL99DISINFECTANT N.E.C. | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 12/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 11/24/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 115DR QUALITY | Division of Southeast Imports (DSEI) |
| 9/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 8/7/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Genesis Partnership Company SA's FDA import refusal history?
Genesis Partnership Company SA (FEI: 3016785739) has 11 FDA import refusal record(s) in our database, spanning from 8/7/2020 to 2/4/2021.
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. Genesis Partnership Company SA's FEI number is 3016785739.
What types of violations has Genesis Partnership Company SA received?
Genesis Partnership Company SA 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 Genesis Partnership Company SA come from?
All FDA import refusal data for Genesis Partnership Company SA 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.