Farmamedica, S.A.
⚠️ High Risk
FEI: 3003256551 • Guatemala, Guatemala • GUATEMALA
FEI Number
3003256551
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
2a Calle 34 - 16 Z. 7, , Guatemala, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 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) |
| 4/13/2020 | 76EJISYRINGE, CARTRIDGE | Division of Southeast Imports (DSEI) | |
| 5/25/2018 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2016 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 482NUTRIT LBL | Philadelphia District Office (PHI-DO) |
| 8/6/2014 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 9/10/2010 | 54YAC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | Atlanta District Office (ATL-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 1/26/2009 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 11UNSAFE COL | New England District Office (NWE-DO) |
| 10/22/2008 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 4/4/2008 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | Los Angeles District Office (LOS-DO) | |
| 1/31/2008 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | Los Angeles District Office (LOS-DO) | |
| 1/31/2008 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | Los Angeles District Office (LOS-DO) | |
| 1/8/2008 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/8/2008 | 54AYA99VITAMIN, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/8/2008 | 54AYA99VITAMIN, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/8/2008 | 54AYA99VITAMIN, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 12/19/2007 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 12/19/2007 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 5/18/2007 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 5/31/2006 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 5/31/2006 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 5/31/2006 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 5/30/2006 | 54AYC99VITAMIN, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/30/2006 | 54AYC99VITAMIN, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/30/2006 | 54AYC99VITAMIN, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/30/2006 | 54AYC99VITAMIN, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/30/2006 | 54AYC99VITAMIN, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 10/26/2005 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 12/15/2004 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/24/2004 | 54AYC99VITAMIN, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 1/23/2003 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Farmamedica, S.A.'s FDA import refusal history?
Farmamedica, S.A. (FEI: 3003256551) has 37 FDA import refusal record(s) in our database, spanning from 1/23/2003 to 5/14/2025.
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. Farmamedica, S.A.'s FEI number is 3003256551.
What types of violations has Farmamedica, S.A. received?
Farmamedica, S.A. has been cited for 7 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 Farmamedica, S.A. come from?
All FDA import refusal data for Farmamedica, S.A. 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.