Merck S.A. De C.V.
⚠️ Moderate Risk
FEI: 3009627688 • Guatemala, Guatemala • GUATEMALA
FEI Number
3009627688
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Calle 5 No 7 Naucalpan De Juarezedo De, z. 1, Guatemala, Guatemala, Guatemala
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 2/22/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Merck S.A. De C.V.'s FDA import refusal history?
Merck S.A. De C.V. (FEI: 3009627688) has 3 FDA import refusal record(s) in our database, spanning from 2/22/2016 to 1/6/2023.
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. Merck S.A. De C.V.'s FEI number is 3009627688.
What types of violations has Merck S.A. De C.V. received?
Merck 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 Merck S.A. De C.V. come from?
All FDA import refusal data for Merck 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.