Biokemical, S.A. de C.V
⚠️ Moderate Risk
FEI: 3004697958 • Santo Tomas, San Salvador • EL SALVADOR
FEI Number
3004697958
Location
Santo Tomas, San Salvador
Country
EL SALVADORAddress
Calle Alberto Masferrer No 174-A, Autopista Comalapa Kilometro 17 1/2, Santo Tomas, San Salvador, El Salvador
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).
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2023 | 54KGY14GLUCOSAMINE HYDROCHLORIDE (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 54ACP90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 54ACP90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/2/2022 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 9/17/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/14/2020 | 54AYY99VITAMIN, N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 1/26/2012 | 54YCK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 12/14/2011 | 54ACY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Southwest Import District Office (SWI-DO) | |
| 7/20/2011 | 41GGY01NUTRITIONALLY COMPLETE FORMULATIONS | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 2/11/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 6/3/2010 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Atlanta District Office (ATL-DO) | |
| 6/3/2010 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Atlanta District Office (ATL-DO) | |
| 6/1/2010 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Biokemical, S.A. de C.V's FDA import refusal history?
Biokemical, S.A. de C.V (FEI: 3004697958) has 13 FDA import refusal record(s) in our database, spanning from 6/1/2010 to 4/26/2023.
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. Biokemical, S.A. de C.V's FEI number is 3004697958.
What types of violations has Biokemical, S.A. de C.V received?
Biokemical, S.A. de C.V has been cited for 8 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 Biokemical, S.A. de C.V come from?
All FDA import refusal data for Biokemical, 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.